Cranial nerve non-invasive neuromodulation (CN-NINM) for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre de recherche sur le vieillissement, Sherbrooke, Canada
Stroke
Cranial nerve non-invasive neuromodulation (CN-NINM) - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Following a stroke, individuals experience pain in the affected upper limb (UL) and residual weakness in the UL, which impacts their quality of life and performance of activities of daily living. To overcome these deficits, exercises are a key element to any rehabilitation program and are based on the reorganization capacity of the central nervous system (called neuroplasticity). To optimize the beneficial effects of exercises and potentiate neuroplasticity, non-invasive brain stimulation devices (NIBS) are increasingly used as a complementary therapy post stroke. Among NIBS, a new technique, called cranial nerve non-invasive neuromodulation (CN-NINM), is making its way into stroke rehabilitation since, unlike other NIBS such as tDCS, it allows the generation of a direct flow of neuronal impulses via the stimulation of the tongue. The goal of this project is therefore to investigate CN-NINM to document its feasibility and explore its efficacy at improving motor recovery and reduce pain at the affected UL in chronic stroke patients (> 6 months). CN-NINM will be applied for 20 minutes during each exercise session of the UL (3X/week, 4 weeks). Feasibility data will comprise adherence to CN-NINM, drop out rate and adverse events and UL motor recovery and pain will be assessed before and after the exercise program. At the end of this study, it is expected that it will be feasible to use CN-NINM as an intervention in combination with the exercise program and that it will result in improved motor function and reduced pain in affected UL.

Treatment Effectiveness

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: Information will be assessed through study completion, an average of 9 months

Week 28
Recruitment rate for the project
Month 9
Dropped out rate of the project in percent and the reasons
Month 9
Adherence to the intervention (training program and CN-NINM) in percent
Month 7
Refusal to participate and the reasons
Month 9
Number of participants with CN-NINM-related adverse events as assessed by a questionnaire
The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.
Change in UL functional performance on the Wolf Motor Function Test
Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale
Change in affected grip strength on the JAMAR dynamometer
Change in manual dexterity on the Box and Block test
Change in participants' subjective real life functional UL performance on the Motor Activity Log
The assessments will be done at the baseline and just after the 20 minutes of application of the CN-NINM.
Change in pain intensity on the CoVAS

Trial Safety

Trial Design

2 Treatment Groups

Cranial nerve non-invasive neuromodulation (CN-NINM)
1 of 2
strength training intervention
1 of 2
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Cranial nerve non-invasive neuromodulation (CN-NINM) · No Placebo Group · N/A

Cranial nerve non-invasive neuromodulation (CN-NINM)
Procedure
Experimental Group · 1 Intervention: Cranial nerve non-invasive neuromodulation (CN-NINM) · Intervention Types: Procedure
strength training intervention
Procedure
Experimental Group · 1 Intervention: Strength training intervention · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: information will be assessed through study completion, an average of 9 months

Trial Background

Marie-Hélène Milot, Principal Investigator
Principal Investigator
Université de Sherbrooke
Closest Location: Centre de recherche sur le vieillissement · Sherbrooke, Canada
2014First Recorded Clinical Trial
4 TrialsResearching Stroke
8 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have motor recovery in the upper limb (UL).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.