ClinicalTrials.gg
RecruitingNCT07260903Updated Dec 3, 2025

Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.

An interventional study of Photobiomodulation and Sham 8-weeks photobiomodulation in Age >60, sponsored by University of Central Lancashire. Recruiting at 1 site in United Kingdom. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by University of Central Lancashire · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jun 2025, registered Nov 2025).
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

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.

The 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.

02

Conditions studied

  • Age >60
03

In context

Lead sponsor

University of Central Lancashire is the lead sponsor of 31 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged from 60-80 years
  • Ability to complete written questionnaires independently
  • Able to provide

Exclusion criteria

Exclusion Criteria:

  • Current or past history of head injury
  • Use of medications acting on the central nervous system
  • Active skin conditions on the forehead or scalp
  • Ongoing brain stimulation therapy
  • History of migraines
  • Sensitive skin, allergies
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Sham photobiomodulation

    8-weeks sham photobiomodulation. The sham device will follow the same protocol but without active light emission.

    Other: Sham 8-weeks photobiomodulation

  • Experimental
    Photobiomodulation

    8-weeks photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). Three times per week for 8-weeks.

    Device: Photobiomodulation

Interventions

  • DevicePhotobiomodulation

    8-weeks photobiomodulation

  • OtherSham 8-weeks photobiomodulation

    The sham device will follow the same protocol but without active light emission.

06

What researchers measure

Primary outcomes

  1. n-1-back (deviation)

    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.

    Time frame: Baseline

  2. n-1-back (deviation)

    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.

    Time frame: 1 hour

  3. n-1-back (deviation)

    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.

    Time frame: 8-weeks

Secondary outcomes

  1. n-2-back (deviation)

    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.

    Time frame: Baseline

  2. n-2-back (deviation)

    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.

    Time frame: 1 hour

  3. n-2-back (deviation)

    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.

    Time frame: 8-weeks

  4. n-1-back (post-deviation)

    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.

    Time frame: Baseline

  5. n-1-back (post-deviation)

    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.

    Time frame: 1 hour

  6. n-1-back (post-deviation)

    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.

    Time frame: 8-weeks

  7. n-2-back (post-deviation)

    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.

    Time frame: Baseline

  8. n-2-back (post-deviation)

    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.

    Time frame: 1 hour

  9. n-2-back (post-deviation)

    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.

    Time frame: 8-weeks

  10. n-1-back (post-target)

    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.

    Time frame: Baseline

  11. n-1-back (post-target)

    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.

    Time frame: 1 hour

  12. n-1-back (post-target)

    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.

    Time frame: 8-weeks

  13. n-2-back (post-target)

    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.

    Time frame: Baseline

  14. n-2-back (post-target)

    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.

    Time frame: 1 hour

  15. n-2-back (post-target)

    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.

    Time frame: 8-weeks

  16. n-1-back (load)

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

    Time frame: Baseline

  17. n-1-back (load)

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

    Time frame: 1 hour

  18. n-1-back (load)

    The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.

    Time frame: 8-weeks

  19. n-2-back (post-load)

    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.

    Time frame: Baseline

  20. n-2-back (post-load)

    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.

    Time frame: 1 hour

  21. n-2-back (post-load)

    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.

    Time frame: 8-weeks

  22. Coop-Wonka chart

    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.

    Time frame: Baseline

  23. Coop-Wonka chart

    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.

    Time frame: 1 hour

  24. Coop-Wonka chart

    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.

    Time frame: 8-weeks

  25. Beck Depression Inventory

    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.

    Time frame: Baseline

  26. Beck Depression Inventory

    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.

    Time frame: 1 hour

  27. Beck Depression Inventory

    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.

    Time frame: 8-weeks

  28. Pittsburgh Sleep Quality Index

    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.

    Time frame: Baseline

  29. Pittsburgh Sleep Quality Index

    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.

    Time frame: 1 hour

  30. Pittsburgh Sleep Quality Index

    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.

    Time frame: 8-weeks

  31. State Trait Anxiety Inventory

    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.

    Time frame: Baseline

  32. State Trait Anxiety Inventory

    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.

    Time frame: 1 hour

  33. State Trait Anxiety Inventory

    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.

    Time frame: 8-weeks

  34. Insomnia Severity Index

    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.

    Time frame: Baseline

  35. Insomnia Severity Index

    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.

    Time frame: 1 hour

  36. Insomnia Severity Index

    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.

    Time frame: 8-weeks

  37. Epworth Sleepiness Scale

    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.

    Time frame: Baseline

  38. Epworth Sleepiness Scale

    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.

    Time frame: 1 hour

  39. Epworth Sleepiness Scale

    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.

    Time frame: 8-weeks

  40. Everyday Memory Errors Questionnaire

    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.

    Time frame: Baseline

  41. Everyday Memory Errors Questionnaire

    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.

    Time frame: 1 hour

  42. Everyday Memory Errors Questionnaire

    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.

    Time frame: 8-weeks

  43. Falls Efficacy

    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.

    Time frame: Baseline

  44. Falls Efficacy

    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.

    Time frame: 1 hour

  45. Falls Efficacy

    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.

    Time frame: 8-weeks

  46. Anterior-posterior balance

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

    Time frame: Baseline

  47. Anterior-posterior balance

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

    Time frame: 1 hour

  48. Anterior-posterior balance

    The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.

    Time frame: 8-weeks

  49. Medio-lateral balance

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

    Time frame: Baseline

  50. Medio-lateral balance

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

    Time frame: 1 hour

  51. Medio-lateral balance

    The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.

    Time frame: 8-weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07260903
Lead sponsor
University of Central Lancashire
Responsible party
Jonathan Sinclair (Professor, University of Central Lancashire) — Principal investigator
First posted
Dec 3, 2025
Start date
Jun 1, 2025
Primary completion
May 1, 2027 (estimated)
Completion
Jul 10, 2027 (estimated)
Last update
Dec 3, 2025

Study contacts

Jonathan Sinclair, DSc
Contact
jksinclair@lancashire.ac.uk
07875651533

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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