AtaxiaNCT07296068
Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.
A study testing Photobiomodulation in people with Ataxia, run by University of Central Lancashire at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ataxia
- What is being tested?
- Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2027to 10 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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 informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Central Lancashire
Preston, Lancashire, PR1 2HE
Sinclair, 07875651533, jksinclair@lancashire.ac.uk
About this study
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).
Read more
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.
- Conditions
- Ataxia
- Being tested
- Photobiomodulation, Sham photobiomodulation
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Photobiomodulation
Sham photobiomodulationOther
The sham device will follow the same protocol but without active light emission.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator: Sham photobiomodulation | Placebo comparator | Sham photobiomodulation. The sham device will follow the same protocol but without active light emission. Receives: Other: Sham photobiomodulation |
| Photobiomodulation | Experimental | Acute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). Receives: Device: Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 1 hour
Secondary outcomes (34)
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
n-1-back (load)
The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.
Measured: Baseline
n-1-back (load)
The n-1-back (load) condition measures working memory performance under the cognitive demand of tracking stimuli 1 trial back.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
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.
Measured: Baseline
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.
Measured: 1 hour
Anterior-posterior balance
The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.
Measured: Baseline
Anterior-posterior balance
The maximum anterior-posterior displacement of the centre of pressure during a two-minute balance task.
Measured: 1 hour
Medio-lateral balance
The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.
Measured: Baseline
Medio-lateral balance
The maximum medio-lateral displacement of the centre of pressure during a two-minute balance task.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion10 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Sinclair, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296068
- Sponsor's protocol ID
- PMB Ataxia pilot feasibility s
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07296068
- Acronym / sponsor ID
- PMB Ataxia pilot feasibility s
- Conditions
- Ataxia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 10 Dec 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator: Sham photobiomodulation | Placebo comparator | Other: Sham photobiomodulationSham photobiomodulation. The sham device will follow the same protocol but without active light emission. |
| Photobiomodulation | Experimental | Device: PhotobiomodulationAcute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationPhotobiomodulation | Device | Photobiomodulation |
| Sham photobiomodulationThe sham device will follow the same protocol but without active light emission. | Other | Sham Comparator: Sham photobiomodulation |
Primary outcome
n-1-back (deviation)
Time frame: Baseline
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.
n-1-back (deviation)
Time frame: 1 hour
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.
34 secondary outcomes
n-2-back (deviation)
Time frame: Baseline
n-2-back (deviation)
Time frame: 1 hour
n-1-back (post-deviation)
Time frame: Baseline
n-1-back (post-deviation)
Time frame: 1 hour
n-2-back (post-deviation)
Time frame: Baseline
n-2-back (post-deviation)
Time frame: 1 hour
n-1-back (post-target)
Time frame: Baseline
n-1-back (post-target)
Time frame: 1 hour
n-2-back (post-target)
Time frame: Baseline
n-2-back (post-target)
Time frame: 1 hour
n-1-back (load)
Time frame: Baseline
n-1-back (load)
Time frame: 1 hour
n-2-back (post-load)
Time frame: Baseline
n-2-back (post-load)
Time frame: 1 hour
Coop-Wonka chart
Time frame: Baseline
Coop-Wonka chart
Time frame: 1 hour
Beck Depression Inventory
Time frame: Baseline
Beck Depression Inventory
Time frame: 1 hour
Pittsburgh Sleep Quality Index
Time frame: Baseline
Pittsburgh Sleep Quality Index
Time frame: 1 hour
State Trait Anxiety Inventory
Time frame: Baseline
State Trait Anxiety Inventory
Time frame: 1 hour
Insomnia Severity Index
Time frame: Baseline
Insomnia Severity Index
Time frame: 1 hour
Epworth Sleepiness Scale
Time frame: Baseline
Epworth Sleepiness Scale
Time frame: 1 hour
Everyday Memory Errors Questionnaire
Time frame: Baseline
Everyday Memory Errors Questionnaire
Time frame: 1 hour
Falls Efficacy
Time frame: Baseline
Falls Efficacy
Time frame: 1 hour
Anterior-posterior balance
Time frame: Baseline
Anterior-posterior balance
Time frame: 1 hour
Medio-lateral balance
Time frame: Baseline
Medio-lateral balance
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Ataxia, run by University of Central Lancashire at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan J Sinclair, DSc (+44787565153, jksinclair@lancashire.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
n-1-back (deviation) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.