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Search / Trial NCT06386510

Cranial Nerve Neuromodulation to Improve Arm Function and Brain Plasticity in Stroke

Launched by UNIVERSITÉ DE SHERBROOKE · Apr 23, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Cranial Nerve Non Invasive Neuromodulation Brain Plasticity Recovery Strength Training Transcranial Magnetic Stimulation

ClinConnect Summary

This clinical trial is studying a new way to help people recover arm movement after having a stroke. Researchers are looking at a technique called cranial nerve non-invasive neuromodulation (CN-NINM), which uses gentle stimulation of the nerves in the tongue to potentially improve brain function and arm recovery. The goal is to see if combining this technique with personalized training for the affected arm can enhance recovery in stroke survivors who are at least six months post-stroke.

To participate in this trial, individuals must be at least 18 years old, have experienced a specific type of stroke, and show some ability to move their affected arm. However, those with certain conditions, such as severe muscle stiffness or significant sensory loss in their arm, will not be eligible. Participants will engage in a four-week training program, and they will undergo assessments before and after the program to measure any improvements in arm movement and brain changes. This study aims to provide more information on how this new approach can support stroke recovery, both in clinics and at home.

Gender

ALL

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.

About Université De Sherbrooke

The Université de Sherbrooke is a leading research institution in Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. With a focus on interdisciplinary collaboration, the university actively engages in clinical trials to explore new therapeutic interventions and improve patient care. Its research team comprises experienced professionals dedicated to ensuring the highest ethical standards and scientific rigor in clinical research. The Université de Sherbrooke strives to translate research findings into practical solutions that enhance health outcomes and contribute to the advancement of medical science.

Locations

Sherbrooke, Quebec, Canada

Laval, Quebec, Canada

Québec, , Canada

Québec, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

Marie-Helene Milot, PhD

Principal Investigator

Université de Sherbrooke

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported