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

University of Central Lancashire

Status: Begins enrollment in 3 months

Conditions: Ataxia

Treatments: Device: Photobiomodulation; Other: Sham photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07296068

PMB Ataxia pilot feasibility s

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

20 participants in 2 patient groups, including a placebo group

Sham Comparator: Sham photobiomodulation

Placebo Comparator group

Description:

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

Treatment:

Other: Sham photobiomodulation

Photobiomodulation

Experimental group

Description:

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

Treatment:

Device: Photobiomodulation