Clinical trial for Stroke
Official title Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke
ClinicalTrials.gov ID: NCT06386510
What this study is testing
- What it's testing
- This study is testing whether stimulating the tongue’s nerves can improve arm function and brain plasticity after a stroke.
- Who it's for
- You may be able to join if you had a stroke more than six months ago and still have arm weakness.
- What's involved
- You will do a 4‑week arm training program at home while a device gently stimulates your tongue. Some days the device will be real, other days it will be a pretend treatment. You will have a few check‑ins with the research team to measure arm strength and brain activity.
- Time commitment
- The study lasts about 4 weeks, with a few visits for assessments before and after the training program.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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.
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Laval, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Laval, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.