Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-29 @ 9:04 AM
Study NCT ID:
NCT07296068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001259', 'term': 'Ataxia'}], 'ancestors': [{'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}], 'ancestors': [{'id': 'D053685', 'term': 'Laser Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D010789', 'term': 'Phototherapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2025-12-08', 'studyFirstSubmitQcDate': '2025-12-08', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'n-1-back (deviation)', 'timeFrame': 'Baseline', 'description': 'The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.'}, {'measure': 'n-1-back (deviation)', 'timeFrame': '1 hour', 'description': 'The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.'}], 'secondaryOutcomes': [{'measure': 'n-2-back (deviation)', 'timeFrame': 'Baseline', 'description': 'The n-2-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-2 trials earlier.'}, {'measure': 'n-2-back (deviation)', 'timeFrame': '1 hour', 'description': 'The n-2-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-2 trials earlier.'}, {'measure': 'n-1-back (post-deviation)', 'timeFrame': 'Baseline', 'description': 'The n-1-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-1 trials earlier.'}, {'measure': 'n-1-back (post-deviation)', 'timeFrame': '1 hour', 'description': 'The n-1-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-1 trials earlier.'}, {'measure': 'n-2-back (post-deviation)', 'timeFrame': 'Baseline', 'description': 'The n-2-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-2 trials earlier.'}, {'measure': 'n-2-back (post-deviation)', 'timeFrame': '1 hour', 'description': 'The n-2-back (post-deviation) task assesses working memory performance on the trial immediately following a deviation from the stimulus presented n-2 trials earlier.'}, {'measure': 'n-1-back (post-target)', 'timeFrame': 'Baseline', 'description': 'The n-1-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-1 trials earlier.'}, {'measure': 'n-1-back (post-target)', 'timeFrame': '1 hour', 'description': 'The n-1-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-1 trials earlier.'}, {'measure': 'n-2-back (post-target)', 'timeFrame': 'Baseline', 'description': 'The n-2-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-2 trials earlier.'}, {'measure': 'n-2-back (post-target)', 'timeFrame': '1 hour', 'description': 'The n-2-back (post-target) task assesses working memory performance on the trial immediately following a target that matched the stimulus presented n-2 trials earlier.'}, {'measure': 'n-1-back (load)', 'timeFrame': 'Baseline', 'description': 'The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.'}, {'measure': 'n-1-back (load)', 'timeFrame': '1 hour', 'description': 'The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.'}, {'measure': 'n-2-back (post-load)', 'timeFrame': 'Baseline', 'description': 'The n-2-back (post-load) condition assesses working memory performance on the trial immediately following a high cognitive load in the n-2-back task.'}, {'measure': 'n-2-back (post-load)', 'timeFrame': '1 hour', 'description': 'The n-2-back (post-load) condition assesses working memory performance on the trial immediately following a high cognitive load in the n-2-back task.'}, {'measure': 'Coop-Wonka chart', 'timeFrame': 'Baseline', 'description': 'The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.'}, {'measure': 'Coop-Wonka chart', 'timeFrame': '1 hour', 'description': 'The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'Baseline', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'Beck Depression Inventory', 'timeFrame': '1 hour', 'description': 'Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': 'Baseline', 'description': 'The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '1 hour', 'description': 'The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': 'Baseline', 'description': 'The state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'State Trait Anxiety Inventory', 'timeFrame': '1 hour', 'description': 'The state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Baseline', 'description': 'The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '1 hour', 'description': 'The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': 'Baseline', 'description': 'The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}, {'measure': 'Epworth Sleepiness Scale', 'timeFrame': '1 hour', 'description': 'The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.'}, {'measure': 'Everyday Memory Errors Questionnaire', 'timeFrame': 'Baseline', 'description': 'The Everyday Memory Errors Questionnaire is a brief self-report instrument designed to assess the frequency of memory lapses in daily life. It consists of multiple items that yield a total score reflecting the extent of everyday memory difficulties.'}, {'measure': 'Everyday Memory Errors Questionnaire', 'timeFrame': '1 hour', 'description': 'The Everyday Memory Errors Questionnaire is a brief self-report instrument designed to assess the frequency of memory lapses in daily life. It consists of multiple items that yield a total score reflecting the extent of everyday memory difficulties.'}, {'measure': 'Falls Efficacy', 'timeFrame': 'Baseline', 'description': 'The Falls Efficacy Scale is a brief self-report instrument designed to assess confidence in performing daily activities without falling. It consists of multiple items that yield a total score reflecting fear of falling and perceived fall-related self-efficacy.'}, {'measure': 'Falls Efficacy', 'timeFrame': '1 hour', 'description': 'The Falls Efficacy Scale is a brief self-report instrument designed to assess confidence in performing daily activities without falling. It consists of multiple items that yield a total score reflecting fear of falling and perceived fall-related self-efficacy.'}, {'measure': 'Anterior-posterior balance', 'timeFrame': 'Baseline', 'description': 'The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.'}, {'measure': 'Anterior-posterior balance', 'timeFrame': '1 hour', 'description': 'The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.'}, {'measure': 'Medio-lateral balance', 'timeFrame': 'Baseline', 'description': 'The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.'}, {'measure': 'Medio-lateral balance', 'timeFrame': '1 hour', 'description': 'The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ataxia']}, 'descriptionModule': {'briefSummary': 'Cerebellar ataxias cause progressive impairments in balance, gait coordination, motor timing, and cognitive functions such as attention and executive control (Buckner, 2013; Salmi et al., 2010; Timmann \\& Daum, 2007). These symptoms substantially reduce independence and quality of life, and current treatments remain limited. There is an urgent need for safe, low-burden interventions that can support everyday functioning and potentially enhance compensatory neural processes.\n\nTranscranial photobiomodulation (tPBM) uses red and near-infrared light (600-1100 nm) to modulate mitochondrial cytochrome-c oxidase, increasing ATP production, reducing oxidative stress, and improving cerebral blood flow (Hamblin, 2016; Salehpour et al., 2019). Several studies show that tPBM can acutely improve cognitive performance and motor control in both healthy adults and clinical groups (Barrett \\& Gonzalez-Lima, 2013; Chan et al., 2019; Henderson \\& Morries, 2017). A growing neurobiological literature suggests that light can penetrate posterior cortical areas sufficiently to modulate networks involving cerebellar-cortical loops (Jagdeo et al., 2012).\n\nImportantly for ataxia, preliminary work shows that tPBM may acutely improve balance stability and gait metrics in older adults and patients with neurological conditions (Moro et al., 2022; Shin et al., 2021). In our own laboratory, we have observed immediate improvements in sway range and cognitive control in older adults after a 24-minute tPBM session applied over midline and posterior scalp regions. These medium to large size effects are consistent with enhanced sensorimotor integration and improved control of attention in distracting environments.\n\nGiven that individuals with cerebellar ataxia experience both motor incoordination and difficulties in maintaining cognitive stability under distracting conditions, tPBM is a promising non-pharmacological intervention worth preliminary investigation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-70 years (inclusive)\n* Diagnosis of ataxia\n* Able to walk independently for at least 5 minutes, with or without an assistive device\n* Able to stand safely for balance testing, with or without an assistive device\n* Hemodynamically stable (stable blood pressure and heart rate at rest)\n* On a stable medication regimen for ≥4 weeks prior to enrolment\n* Sufficient vision and hearing (with usual aids if required) to complete balance and cognitive assessments\n* Able to complete study questionnaires and cognitive tasks (with assistance for reading/writing if required)\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Current or past history of head injury\n* Use of medications acting on the central nervous system\n* Active skin conditions on the forehead or scalp\n* Any other major neurological disorder that could independently affect balance or cognition\n* Ongoing brain stimulation therapy\n* History of migraines\n* Sensitive skin, allergies'}, 'identificationModule': {'nctId': 'NCT07296068', 'briefTitle': 'Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Lancashire'}, 'officialTitle': 'Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'PMB Ataxia pilot feasibility s'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Comparator: Sham photobiomodulation', 'description': 'Sham photobiomodulation. The sham device will follow the same protocol but without active light emission.', 'interventionNames': ['Other: Sham photobiomodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation', 'description': 'Acute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm).', 'interventionNames': ['Device: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'description': 'Photobiomodulation', 'armGroupLabels': ['Photobiomodulation']}, {'name': 'Sham photobiomodulation', 'type': 'OTHER', 'description': 'The sham device will follow the same protocol but without active light emission.', 'armGroupLabels': ['Sham Comparator: Sham photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PR1 2HE', 'city': 'Preston', 'state': 'Lancashire', 'country': 'United Kingdom', 'contacts': [{'name': 'Sinclair', 'role': 'CONTACT', 'email': 'jksinclair@lancashire.ac.uk', 'phone': '07875651533'}], 'facility': 'University of Central Lancashire', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'Jonathan J Sinclair, DSc', 'role': 'CONTACT', 'email': 'jksinclair@lancashire.ac.uk', 'phone': '+44787565153'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Central Lancashire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jonathan Sinclair', 'investigatorAffiliation': 'University of Central Lancashire'}}}}