ClinicalTrials.gg
Not yet recruitingNCT07296068Updated Sep 22, 2026

Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.

An interventional study of Photobiomodulation and Sham photobiomodulation in Ataxia, sponsored by University of Central Lancashire. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Transcranial 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).

Importantly 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.

Given 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.

02

Conditions studied

  • Ataxia

Browse trials for

03

In context

Ataxia

149 studies on the registry are indexed under Ataxia; 37 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 100 interventional studies indexed under Ataxia.

Browse Ataxia studies →

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
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Age 18-70 years (inclusive)
  • Diagnosis of ataxia
  • Able to walk independently for at least 5 minutes, with or without an assistive device
  • Able to stand safely for balance testing, with or without an assistive device
  • Hemodynamically stable (stable blood pressure and heart rate at rest)
  • On a stable medication regimen for ≥4 weeks prior to enrolment
  • Sufficient vision and hearing (with usual aids if required) to complete balance and cognitive assessments
  • Able to complete study questionnaires and cognitive tasks (with assistance for reading/writing if required)
  • Able and willing to provide written

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
  • Any other major neurological disorder that could independently affect balance or cognition
  • 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
20 participants (estimated)

Study arms

  • Placebo comparator
    Sham Comparator: Sham photobiomodulation

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

    Other: Sham photobiomodulation

  • Experimental
    Photobiomodulation

    Acute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm).

    Device: Photobiomodulation

Interventions

  • DevicePhotobiomodulation

    Photobiomodulation

  • OtherSham 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

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-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

  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: 1 hour

  5. 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

  6. 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

  7. 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

  8. 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

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

    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.

    Time frame: Baseline

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

    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.

    Time frame: 1 hour

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. Anterior-posterior balance

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

    Time frame: Baseline

  32. Anterior-posterior balance

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

    Time frame: 1 hour

  33. Medio-lateral balance

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

    Time frame: Baseline

  34. Medio-lateral balance

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

    Time frame: 1 hour

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Jun 2027, 5 months later.

Of 53 non-industry interventional studies with no phase under Ataxia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's planned 5 months is below that.

Counting every sponsor, half of 55 studies reached it within 19 months; a quarter within 7 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2025
First posted
Dec 22, 2025
StartEst.
Jan 1, 2027
Primary completionEst.
Jun 1, 2027
CompletionEst.
Dec 10, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07296068
Lead sponsor
University of Central Lancashire
Responsible party
Jonathan Sinclair (Professor, University of Central Lancashire) — Principal investigator
First posted
Dec 22, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Dec 10, 2027 (estimated)
Last update
Sep 22, 2026

Study contacts

Jonathan J Sinclair, DSc
Contact
jksinclair@lancashire.ac.uk
+44787565153

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion