Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
Study NCT ID:
NCT07260903
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D028022', 'term': 'Low-Level Light Therapy'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], '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': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', '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.'}, {'measure': 'n-1-back (deviation)', 'timeFrame': '8-weeks', '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-2-back (deviation)', 'timeFrame': '8-weeks', '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-1-back (post-deviation)', 'timeFrame': '8-weeks', '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-2-back (post-deviation)', 'timeFrame': '8-weeks', '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-1-back (post-target)', 'timeFrame': '8-weeks', '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': 'he 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': 'he 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': '8-weeks', 'description': 'he 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-1-back (load)', 'timeFrame': '8-weeks', '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': 'n-2-back (post-load)', 'timeFrame': '8-weeks', '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': 'Coop-Wonka chart', 'timeFrame': '8-weeks', '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': 'Beck Depression Inventory', 'timeFrame': '8-weeks', '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': 'Pittsburgh Sleep Quality Index', 'timeFrame': '8-weeks', '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': 'State Trait Anxiety Inventory', 'timeFrame': '8-weeks', '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': 'Insomnia Severity Index', 'timeFrame': '8-weeks', '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': 'Epworth Sleepiness Scale', 'timeFrame': '8-weeks', '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': 'Everyday Memory Errors Questionnaire', 'timeFrame': '8-weeks', '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': 'Falls Efficacy', 'timeFrame': '8-weeks', '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': 'Anterior-posterior balance', 'timeFrame': '8-weeks', '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.'}, {'measure': 'Medio-lateral balance', 'timeFrame': '8-weeks', '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': ['Age >60']}, 'descriptionModule': {'briefSummary': 'As people age, changes in balance and memory can make daily life more difficult and increase the risk of falls. Falls are one of the main causes of injury, hospitalization and loss of independence in older adults, while even mild declines in memory and concentration can reduce confidence, social participation and overall quality of life. Therefore, safe, affordable, and practical ways to help older adults remain steady on their feet and mentally sharp are urgently needed.\n\nThe aim of this project is therefore to conduct a pilot feasibility randomized controlled trial to examine whether regular home-based photobiomodulation can improve balance and cognitive function in adults aged over 60. If successful, this research could help shape future strategies for preventing falls, enhancing wellbeing and maintaining independence in older people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged from 60-80 years\n* Ability to complete written questionnaires independently\n* Able to provide 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* Ongoing brain stimulation therapy\n* History of migraines\n* Sensitive skin, allergies'}, 'identificationModule': {'nctId': 'NCT07260903', 'briefTitle': 'Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.', 'organization': {'class': 'OTHER', 'fullName': 'University of Central Lancashire'}, 'officialTitle': 'Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'PMB balance and cognition'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham photobiomodulation', 'description': '8-weeks sham photobiomodulation.\n\nThe sham device will follow the same protocol but without active light emission.', 'interventionNames': ['Other: Sham 8-weeks photobiomodulation']}, {'type': 'EXPERIMENTAL', 'label': 'Photobiomodulation', 'description': '8-weeks photobiomodulation\n\nTwenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). Three times per week for 8-weeks.', 'interventionNames': ['Device: Photobiomodulation']}], 'interventions': [{'name': 'Photobiomodulation', 'type': 'DEVICE', 'description': '8-weeks photobiomodulation', 'armGroupLabels': ['Photobiomodulation']}, {'name': 'Sham 8-weeks photobiomodulation', 'type': 'OTHER', 'description': 'The sham device will follow the same protocol but without active light emission.', 'armGroupLabels': ['Sham photobiomodulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PR4 0PE', 'city': 'Preston', 'state': 'Lancashire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jonathan Sinclair, DSc', 'role': 'CONTACT', 'email': 'jksinclair@lancashire.ac.uk', 'phone': '07875651533'}], 'facility': 'University of Central Lancashire', 'geoPoint': {'lat': 53.76282, 'lon': -2.70452}}], 'centralContacts': [{'name': 'Jonathan Sinclair, DSc', 'role': 'CONTACT', 'email': 'jksinclair@lancashire.ac.uk', 'phone': '07875651533'}]}, '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'}}}}