---
title: "Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial."
nct_id: NCT07296068
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: University of Central Lancashire
study_type: INTERVENTIONAL
primary_condition: Ataxia
countries: United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07296068.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07296068"
ct_last_update_post_date: 2025-12-22
last_seen_at: "2026-05-12T06:03:47.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Can Acute Photobiomodulation Improve Balance and Cognition in Individuals With Ataxia: a Pilot Feasibility Placebo Randomized Controlled Trial.

**NCT ID:** [NCT07296068](https://clinicaltrials.gov/study/NCT07296068)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** University of Central Lancashire
- **Conditions:** Ataxia
- **Start Date:** 2026-06-01
- **Completion Date:** 2027-12-10
- **CT.gov Last Update:** 2025-12-22

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Sham Comparator: Sham photobiomodulation** (PLACEBO_COMPARATOR) — Sham photobiomodulation. The sham device will follow the same protocol but without active light emission.
- **Photobiomodulation** (EXPERIMENTAL) — Acute photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm).

## Interventions

- **Photobiomodulation** (DEVICE) — Photobiomodulation
- **Sham photobiomodulation** (OTHER) — The sham device will follow the same protocol but without active light emission.

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- University of Central Lancashire, Preston, Lancashire, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of central lancashire|preston|lancashire|united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07296068.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07296068*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*