| Registry | NCT07296068 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 20 (Estimated) |
| Sponsor | University of Central Lancashire (Other) |
| Conditions | Ataxia |
| Interventions | Photobiomodulation, Sham photobiomodulation (Device, other) |
| Dates | start 2027-01-01 (estimated), primary completion 2027-06-01 (estimated), completion 2027-12-10 (estimated), first posted 2025-12-22, last updated 2026-09-22 |
| Locations | 1 site in United Kingdom |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sham Comparator: Sham photobiomodulation | Placebo comparator | Other: Sham photobiomodulation | Sham photobiomodulation. The sham device will follow the same protocol but without active light emission. |
| Photobiomodulation | Experimental | Device: Photobiomodulation | Acute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). |
Sex: All, ages: 18 Years to 70 Years
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 informed consent 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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Central Lancashire | Preston, Lancashire | United Kingdom |