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Article: A Response to: Letter to the Editor Regarding "LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration".

Burton, Ben / Munk, Marion R / Tedford, Stephanie E / Croissant, Cindy L / Rückert, Rene / Tedford, Clark E

Ophthalmology and therapy

2024 Volume 13, Issue 4, Page(s) 1055–1060

Language	English
Publishing date	2024-02-06
Publishing country	England
Document type	Letter
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-024-00896-0
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Article ; Online: Digital solutions for sleep problems in children: A pilot study.

Tedford, Stephanie E / Romano, Lindsay / Gozal, David / Medalie, Lisa

Pediatric pulmonology

2021 Volume 57, Issue 8, Page(s) 1914–1920

Abstract: Children with sleep difficulties have limited options for treatment. Advancements in technology allow for the digital delivery of evidence-based sleep strategies developed with a focus on cognitive behavioral therapy (CBT) approaches for insomnia. An ... ...

Abstract	Children with sleep difficulties have limited options for treatment. Advancements in technology allow for the digital delivery of evidence-based sleep strategies developed with a focus on cognitive behavioral therapy (CBT) approaches for insomnia. An initial survey study was conducted to assess the need and current management of sleep problems in pediatric populations. A secondary pilot study evaluated the effect of a digitally-delivered sleep strategy for the treatment of pediatric sleep problems. In the pilot study, participants had access to a mobile application which provided individualized CBT-focused sleep solutions delivered over 6-10 weeks. A total of 218 participants were surveyed to determine their need and approach for pediatric sleep problems. Approximately 74% reported sleep problems in children aged 0-1 (46%), 2-4 (67%), 5-12 (85%), and 13-17 (73%). In the pilot study, 11 families with pediatric sleep problems (children categorized as baby, toddler and school-aged) were enrolled and received the DrLullaby digital intervention. An improvement in key sleep behavior was observed including "time to fall asleep" (n = 8; 72.7%), "total time asleep" (n = 6; 54.5%) and "time awake" (n = 7; 63.6%). Within group analysis for time awake and time to fall asleep showed a mean change from baseline of 75.6% and 31.3%, respectively. Within group analysis for total time asleep showed a mean improvement of 1 h and 3 min compared to baseline. The collective distress scale score was decreased by 35%. These results suggest viability of the digital delivery of evidence-based sleep strategies for treatment of pediatric sleep problems.
MeSH term(s)	Child ; Cognitive Behavioral Therapy/methods ; Humans ; Pilot Projects ; Sleep ; Sleep Initiation and Maintenance Disorders/therapy ; Treatment Outcome
Language	English
Publishing date	2021-04-15
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	632784-9
ISSN	1099-0496 ; 8755-6863
ISSN (online)	1099-0496
ISSN	8755-6863
DOI	10.1002/ppul.25402
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Article: Non-Invasive Treatment of Early Diabetic Macular Edema by Multiwavelength Photobiomodulation with the Valeda Light Delivery System.

Kaymak, Hakan / Munk, Marion R / Tedford, Stephanie E / Croissant, Cindy L / Tedford, Clark E / Ruckert, Rene / Schwahn, Hartmut

Clinical ophthalmology (Auckland, N.Z.)

2023 Volume 17, Page(s) 3549–3559

Abstract: Purpose: Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes ... ...

Abstract	Purpose: Diabetes is associated with ocular complications including diabetic macular edema (DME). Current therapies are invasive and include repeated intravitreal injections and laser therapy. Photobiomodulation (PBM) is a treatment (Tx) that utilizes selected wavelengths of light to induce cellular benefits including reduction of inflammation and edema. This single-center, open-label, post-hoc analysis explored the utility of multiwavelength PBM in subjects with DME. Methods: Analysis included review of data from patients undergoing standard clinical care with an approved and marketed PBM medical device, the Valeda Results: A total of 30 eyes (19 subjects) were analyzed. Subjects were predominately male (68.4%) with a mean age of 56 ± 14 years. Reductions in central retinal thickness (CRT), resolution of intraretinal fluid (IRF) and improvement in diabetic retinopathy severity scale scores were observed following PBM treatment in select patients. Baseline BCVA remained stable over the follow-up observation period of 3 months post-PBM. Approximately 64% of patients reported subjective improvements in their ocular condition and decreased influence in everyday life. Detailed OCT evaluations confirmed no safety issues related to phototoxicity up to 16 months. Conclusion: Early-stage DME subjects treated with Valeda multiwavelength PBM showed improvements in clinical and anatomical parameters. The Valeda multiwavelength PBM approach demonstrates a favorable safety profile with no signs of phototoxicity following an independent OCT review. PBM therapy may offer an alternative, non-invasive treatment strategy with a unique mechanism and modality for patients with early-stage DME.
Language	English
Publishing date	2023-11-22
Publishing country	New Zealand
Document type	Journal Article
ISSN	1177-5467
ISSN	1177-5467
DOI	10.2147/OPTH.S415883
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Conference proceedings: LIGHTSITE III 24-month analysis: evaluation of multiwavelength photobiomodulation in dry age-related macular degeneration using the lumithera valeda light delivery system

Kaymak, Hakan / Jaffe, Glenn / Munk, Marion / Tedford, Stephanie E. / Croissant, Cindy L. / Walker, Michael / Ruckert, Rene / Tedford, Clark E. / LIGHTSITE III Investigator Team

2023 , Page(s) EPO 6.2

Event/congress	35. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC); Nürnberg; 2023
Keywords	Medizin, Gesundheit
Publishing date	2023-06-13
Publisher	German Medical Science GMS Publishing House; Düsseldorf
Document type	Conference proceedings
DOI	10.3205/23doc090
Database	German Medical Science

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Article: LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.

Burton, Ben / Parodi, Maurizio Battaglia / Jürgens, Ignasi / Zanlonghi, Xavier / Hornan, Dan / Roider, Johann / Lorenz, Katrin / Munk, Marion R / Croissant, Cindy L / Tedford, Stephanie E / Walker, Michael / Ruckert, Rene / Tedford, Clark E

Ophthalmology and therapy

2023 Volume 12, Issue 2, Page(s) 953–968

Abstract: Introduction: Photobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses wavelengths of light to target components of the mitochondrial respiratory chain to improve cellular bioenergetic ... ...

Abstract	Introduction: Photobiomodulation (PBM) represents a potential treatment for non-exudative age-related macular degeneration (AMD). PBM uses wavelengths of light to target components of the mitochondrial respiratory chain to improve cellular bioenergetic outputs. The aim of this study was to further investigate the effects of PBM on clinical, quality of life (QoL) and anatomical outcomes in subjects with intermediate stage non-exudative AMD. Methods: The multicenter LIGHTSITE II study was a randomized clinical trial evaluating safety and efficacy of PBM in intermediate non-exudative AMD. The LumiThera Valeda® Light Delivery System delivered multiwavelength PBM (590, 660 and 850 nm) or sham treatment 3 × per week over 3-4 weeks (9 treatments per series) with repeated treatments at baseline (BL), 4 and 8 months. Subjects were enrolled with 20/32 to 20/100 best-corrected visual acuity (BCVA) and no central geographic atrophy (GA) within the central fovea (500 μm). Results: LIGHTSITE II enrolled 44 non-exudative AMD subjects (53 eyes). PBM-treated eyes showed statistically significant improvement in BCVA at 9 months (n = 32 eyes, p = 0.02) with a 4-letter gain in the PBM-treated group versus a 0.5-letter gain in the sham-treated group (ns, p < 0.1) for patients that received all 27 PBM treatments (n = 29 eyes). Approximately 35.3% of PBM-treated eyes showed ≥ 5-letter improvement at 9 months. Macular drusen volume was not increased over time in the PBM-treated group but did show increases in the sham-treated group. While PBM and sham groups both showed GA lesion growth in the trial period, there was 20% less growth in the PBM group over 10 months, suggesting potential disease-modifying effects. No safety concerns or signs of phototoxicity were observed. Conclusion: These results confirm previous clinical testing of multiwavelength PBM and support treatment with Valeda as a novel therapy with a unique mechanism of action as a potential treatment for non-exudative AMD. Trial registration: Clinicaltrial.Gov Registration Identifier: NCT03878420.
Language	English
Publishing date	2023-01-02
Publishing country	England
Document type	Journal Article
ISSN	2193-8245
ISSN	2193-8245
DOI	10.1007/s40123-022-00640-6
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Article ; Online: Mirtazapine and ketanserin alter preference for gambling-like schedules of reinforcement in rats.

Persons, Amanda L / Tedford, Stephanie E / Celeste, T

Progress in neuro-psychopharmacology & biological psychiatry

2017 Volume 77, Page(s) 178–184

Abstract: Drug and behavioral addictions have overlapping features, e.g., both manifest preference for larger, albeit costlier, reinforcement options in cost/benefit decision-making tasks. Our prior work revealed that the mixed-function serotonergic compound, ... ...

Abstract	Drug and behavioral addictions have overlapping features, e.g., both manifest preference for larger, albeit costlier, reinforcement options in cost/benefit decision-making tasks. Our prior work revealed that the mixed-function serotonergic compound, mirtazapine, attenuates behaviors by rats motivated by abused drugs. To extend this work to behavioral addictions, here we determined if mirtazapine and/or ketanserin, another mixed-function serotonin-acting compound, can alter decision-making in rats that is independent of drug (or food)-motivated reward. Accordingly, we developed a novel variable-ratio task in rats wherein intracranial self-stimulation was used as the positive reinforcer. Using lever pressing for various levels of brain stimulation, the operant task provided choices between a small brain stimulation current delivered on a fixed-ratio schedule (i.e., a predictable reward) and a large brain stimulation delivered following an unpredictable number of responses (i.e., a variable-ratio schedule). This task allowed for demonstration of individualized preference and detection of shifts in motivational influences during a pharmacological treatment. Once baseline preference was established, we determined that pretreatment with mirtazapine or ketanserin significantly decreased preference for the large reinforcer presented after gambling-like schedules of reinforcement. When the rats were tested the next day without drug, preference for the unpredictable large reinforcer option was restored. These data demonstrate that mirtazapine and ketanserin can reduce preference for larger, costlier reinforcement options, and illustrate the potential for these drugs to alter behavior.
MeSH term(s)	Animals ; Choice Behavior/drug effects ; Decision Making/drug effects ; Gambling/psychology ; Ketanserin/pharmacology ; Male ; Mianserin/analogs & derivatives ; Mianserin/pharmacology ; Mirtazapine ; Rats ; Reinforcement Schedule ; Reward ; Self Stimulation/drug effects
Chemical Substances	Mianserin (250PJI13LM) ; Ketanserin (97F9DE4CT4) ; Mirtazapine (A051Q2099Q)
Language	English
Publishing date	2017-04-12
Publishing country	England
Document type	Journal Article
ZDB-ID	781181-0
ISSN	1878-4216 ; 0278-5846
ISSN (online)	1878-4216
ISSN	0278-5846
DOI	10.1016/j.pnpbp.2017.03.027
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Zs.A 1342: Show issues

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Article ; Online: LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the Lumithera Valeda Light Delivery System.

Boyer, David / Hu, Allen / Warrow, David / Xavier, Samantha / Gonzalez, Victor / Lad, Eleonora / Rosen, Richard B / Do, Diana / Schneiderman, Todd / Ho, Allen / Munk, Marion R / Jaffe, Glenn / Tedford, Stephanie E / Croissant, Cindy L / Walker, Michael / Rückert, Rene / Tedford, Clark E

Retina (Philadelphia, Pa.)

2023 Volume 44, Issue 3, Page(s) 487–497

Abstract: Purpose: The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System.: Methods: LIGHTSITE III is a randomized, ... ...

Abstract	Purpose: The LIGHTSITE III study evaluated multiwavelength photobiomodulation (PBM) therapy in nonexudative (dry) age-related macular degeneration (AMD) using the LumiThera Valeda Light Delivery System. Methods: LIGHTSITE III is a randomized, controlled trial to assess the safety and effectiveness of PBM in dry AMD. Subjects were given multiwavelength PBM (590, 660, and 850 nm) or Sham treatment delivered in a series of nine sessions over 3 to 5 weeks every four months over 24 months. Subjects were assessed for efficacy and safety outcomes. Data from the 13-month analysis are presented in this report. Results: A total of 100 subjects (148 eyes) with dry AMD were randomized. LIGHTSITE III met the primary efficacy best-corrected visual acuity endpoint with a significant difference between PBM (n = 91 eyes) and Sham (n = 54 eyes) groups (Between group difference: 2.4 letters (SE 1.15), CI: -4.7 to -0.1, P = 0.02) (PBM alone: 5.4 letters (SE 0.96), CI: 3.5 to 7.3, P < 0.0001; Sham alone: 3.0 letters (SE 1.13), CI: 0.7-5.2, P < 0.0001). The PBM group showed a significant decrease in new onset geographic atrophy ( P = 0.024, Fisher exact test, odds ratio 9.4). A favorable safety profile was observed. Conclusion: LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM therapy.
MeSH term(s)	Humans ; Low-Level Light Therapy ; Prospective Studies ; Visual Acuity ; Macular Degeneration/diagnosis ; Macular Degeneration/radiotherapy ; Macular Degeneration/drug therapy ; Eye ; Geographic Atrophy/diagnosis ; Geographic Atrophy/radiotherapy
Language	English
Publishing date	2023-11-14
Publishing country	United States
Document type	Randomized Controlled Trial ; Journal Article
ZDB-ID	603192-4
ISSN	1539-2864 ; 0275-004X
ISSN (online)	1539-2864
ISSN	0275-004X
DOI	10.1097/IAE.0000000000003980
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Article ; Online: (with research data) Dopaminergic lesions of the dorsolateral striatum in rats increase delay discounting in an impulsive choice task.

Tedford, Stephanie E / Persons, Amanda L / Napier, T Celeste

PloS one

2015 Volume 10, Issue 4, Page(s) e0122063

Abstract: Dysregulated dopamine transmission in striatal circuitry is associated with impulsivity. The current study evaluated the influence of dopaminergic inputs to the dorsolateral striatum on impulsive choice, one aspect of impulsive behavior. We implemented ... ...

Abstract	Dysregulated dopamine transmission in striatal circuitry is associated with impulsivity. The current study evaluated the influence of dopaminergic inputs to the dorsolateral striatum on impulsive choice, one aspect of impulsive behavior. We implemented an operant task that measures impulsive choice in rats via delay discounting wherein intracranial self-stimulation (ICSS) was used as the positive reinforcer. To do so, rats were anesthetized to allow implanting of a stimulating electrode within the lateral hypothalamus of one hemisphere and bilateral dorsal striatal injections of the dopaminergic toxin, 6-OHDA (lesioned) or its vehicle (sham). Following recovery, rats were trained in a delay discounting task wherein they selected between a small ICSS current presented immediately after lever pressing, and a large ICSS current presented following a 0 to 15 s delay upon pressing the alternate lever. Task acquisition and reinforcer discrimination were similar for lesioned and sham rats. All rats exhibited an initial preference for the large reinforcer, and as the delay was increased, preference for the large reinforcer was decreased indicating that the subjective value of the large reinforcer was discounted as a function of delay time. However, this discounting effect was significantly enhanced in lesioned rats for the longer delays. These data reveal a contribution of dopaminergic inputs to the dorsolateral striatum on impulsive choice behavior, and provide new insights into neural substrates underlying discounting behaviors.
MeSH term(s)	Animals ; Behavior, Animal ; Choice Behavior ; Corpus Striatum/physiopathology ; Dopamine/metabolism ; Electric Stimulation ; Hypothalamus/physiopathology ; Impulsive Behavior ; Male ; Rats ; Rats, Sprague-Dawley ; Self Stimulation ; Synaptic Transmission
Chemical Substances	Dopamine (VTD58H1Z2X)
Language	English
Publishing date	2015-04-30
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0122063
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Article: A new approach to assess gambling-like behavior in laboratory rats: using intracranial self-stimulation as a positive reinforcer.

Tedford, Stephanie E / Holtz, Nathan A / Persons, Amanda L / Napier, T Celeste

Frontiers in behavioral neuroscience

2014 Volume 8, Page(s) 215

Abstract: Pathological gambling is one manifestation of impulse control disorders. The biological underpinnings of these disorders remain elusive and treatment is far from ideal. Animal models of impulse control disorders are a critical research tool for ... ...

Abstract	Pathological gambling is one manifestation of impulse control disorders. The biological underpinnings of these disorders remain elusive and treatment is far from ideal. Animal models of impulse control disorders are a critical research tool for understanding this condition and for medication development. Modeling such complex behaviors is daunting, but by its deconstruction, scientists have recapitulated in animals critical aspects of gambling. One aspect of gambling is cost/benefit decision-making wherein one weighs the anticipated costs and expected benefits of a course of action. Risk/reward, delay-based and effort-based decision-making all represent cost/benefit choices. These features are studied in humans and have been translated to animal protocols to measure decision-making processes. Traditionally, the positive reinforcer used in animal studies is food. Here, we describe how intracranial self-stimulation can be used for cost/benefit decision-making tasks and overview our recent studies showing how pharmacological therapies alter these behaviors in laboratory rats. We propose that these models may have value in screening new compounds for the ability to promote and prevent aspects of gambling behavior.
Language	English
Publishing date	2014-06-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2452960-6
ISSN	1662-5153
ISSN	1662-5153
DOI	10.3389/fnbeh.2014.00215
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Article ; Online: Pharmacologically distinct pramipexole-mediated akinesia vs. risk-taking in a rat model of Parkinson's disease.

Holtz, Nathan A / Tedford, Stephanie E / Persons, Amanda L / Grasso, Salvatore A / Napier, T Celeste

Progress in neuro-psychopharmacology & biological psychiatry

2016 Volume 70, Page(s) 77–84

Abstract: Pramipexole and ropinirole are dopamine agonists that are efficacious in treating motor disturbances of neuropathologies, e.g., Parkinson's disease and restless legs syndrome. A significant portion of treated patients develop impulsive/compulsive ... ...

Abstract	Pramipexole and ropinirole are dopamine agonists that are efficacious in treating motor disturbances of neuropathologies, e.g., Parkinson's disease and restless legs syndrome. A significant portion of treated patients develop impulsive/compulsive behaviors. Current treatment is dose reduction or switching to an alternative dopamine replacement, both of which can undermine the motor benefits. Needed is a preclinical model that can assist in identifying adjunct treatments to dopamine agonist therapy that reduce impulsive/compulsive behaviors without interfering with motor benefits of the dopamine agonist. Toward that objective, the current study implemented a rat model of Parkinson's disease to behaviorally profile chronically administered pramipexole. This was accomplished with male Sprague-Dawley rats wherein (i) 6-hydroxydopamine-induced lesions of the dorsolateral striatum produced Parkinson's disease-like akinesia, measured in the forelimbs, (ii) intracranial self-stimulation-mediated probability discounting indicated impulsivity/risk-taking, and (iii) two doses of pramipexole were continuously administered for 14-28days via osmotic minipumps to mirror the chronic, stable exposure achieved with extended release formulations. The atypical antidepressant, mirtazapine, is known to reduce behaviors associated with drug addiction in rats; thus, we demonstrated model utility here by determining the effects of mirtazapine on pramipexole-induced motor improvements versus probability discounting. We observed that forelimb akinesia subsequent to striatal lesions was attenuated by both pramipexole doses tested (0.3 and 1.2mg/kg/day) within 4h of pump implant dispensing 0.3mg/kg/day and 1h by 1.2mg/kg/day. By contrast, 12-14days of infusion with 0.3mg/kg/day did not alter discounting, but increases were obtained with 1.2mg/kg/day pramipexole, with 67% of 1.2mg/kg/day-treated rats meeting categorical criteria for 'high risk-taking'. Insertion of a second minipump delivering mirtazapine did not alter motor function during 14days of co-administration with pramipexole, but was sufficient to attenuate risk-taking. These outcomes revealed distinct probability discounting and anti-akinesia profiles for pramipexole, indicating that pharmacotherapy, (e.g., mirtazapine treatments), can be developed that reduce risk-taking while leaving motor benefits intact.
MeSH term(s)	Animals ; Antidepressive Agents, Tricyclic/pharmacology ; Antiparkinson Agents/adverse effects ; Antiparkinson Agents/pharmacology ; Benzothiazoles/adverse effects ; Benzothiazoles/pharmacology ; Corpus Striatum/drug effects ; Corpus Striatum/physiopathology ; Delay Discounting/drug effects ; Delay Discounting/physiology ; Dopamine Agonists/adverse effects ; Dopamine Agonists/pharmacology ; Dose-Response Relationship, Drug ; Impulsive Behavior/drug effects ; Impulsive Behavior/physiology ; Male ; Mianserin/analogs & derivatives ; Mianserin/pharmacology ; Motor Activity/drug effects ; Motor Activity/physiology ; Oxidopamine ; Parkinsonian Disorders/drug therapy ; Parkinsonian Disorders/physiopathology ; Parkinsonian Disorders/psychology ; Random Allocation ; Rats, Sprague-Dawley ; Risk-Taking ; Self Stimulation/drug effects
Chemical Substances	Antidepressive Agents, Tricyclic ; Antiparkinson Agents ; Benzothiazoles ; Dopamine Agonists ; Mianserin (250PJI13LM) ; pramipexole (83619PEU5T) ; Oxidopamine (8HW4YBZ748) ; mirtazapine (A051Q2099Q)
Language	English
Publishing date	2016--03
Publishing country	England
Document type	Journal Article
ZDB-ID	781181-0
ISSN	1878-4216 ; 0278-5846
ISSN (online)	1878-4216
ISSN	0278-5846
DOI	10.1016/j.pnpbp.2016.05.004
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