Improving arm function and brain recovery in stroke patients

Can Stimulating the Tongue Help Improve Upper Limb Motor Function and Brain Plasticity in Individuals at the Chronic Stage of a Stroke: a Randomized Controlled Trial

This study is testing a new way to help stroke survivors improve their arm function and brain recovery by combining nerve stimulation with strength training.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Université de Sherbrooke (Academic / other)
• Locations: 3 sites (Laval, Quebec and 2 other locations)
• Trial ID: NCT06386510 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of cranial nerve non-invasive neuromodulation combined with strength training on arm function and brain plasticity in individuals who have experienced a stroke. The approach involves assessing the excitability of the corticospinal pathway using transcranial magnetic stimulation (TMS) to tailor rehabilitation interventions based on individual recovery potential. Participants will undergo targeted training to enhance upper limb motor recovery, leveraging neuroplasticity to improve their quality of life and independence. The study aims to provide insights into the efficacy of this innovative rehabilitation strategy for chronic stroke survivors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have had a unilateral supratentorial stroke and show some level of upper limb motor recovery.

Not a fit: Patients with significant spasticity, major sensory deficits, or other neurological disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance upper limb recovery and overall independence for stroke patients.

How similar studies have performed: Previous studies have shown promising results with non-invasive brain stimulation techniques in various neurological populations, suggesting potential efficacy in stroke rehabilitation.

Eligibility criteria

Inclusion Criteria:

* be ≥18 years of age;
* have had a unilateral supratentorial stroke;
* be in a chronic stage of recovery (\>6 months);
* present some UL motor recovery (Fugl-Meyer Stroke Assessment \[FMA-UE\] score ≥25/66);
* are not involved in rehabilitation treatments.

Exclusion Criteria:

* significant spasticity at UL (score \>3 on the modified Ashworth scale);
* major sensory deficit at UL (a score \<25/34 on the Nottingham sensory assessment and a score \<6 on the vibration threshold assessment);
* hemineglect (\> 70% of unshaded lines on the same side as the motor deficit on the Line Cancellation test);
* apraxia (score \>2.5 on the Alexander test);
* a neurological disorder other than stroke-related;
* orthopedic problems at UL;
* cognitive impairment (score \<2/5 on the Mini-Cog);
* significant pain intensity at UL (a score ≥ 6/10 on the Visual Analog Pain Scale);
* absence of MEP (peak-to-peak MEP amplitude \<20μV);
* contraindications to CN-NINM and TMS.

Where this trial is running

Laval, Quebec and 2 other locations

• CRIR/Feil/Oberfeld Research Center; Centre intégré de santé et de services sociaux de Laval; Jewish Rehabilitation Hospital — Laval, Quebec, Canada (Recruiting)
• Cirris — Québec, Quebec, Canada (Recruiting)
• Centre de recherche sur le vieillissement — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Marie-Helene Milot, PhD — Université de Sherbrooke
• Study coordinator: Marie-Helene Milot, PhD

Conditions Stroke; Cranial nerve non-invasive neuromodulation; Brain plasticity; Recovery; Strength training; Transcranial magnetic stimulation