Cranial Nerve Neuromodulation for Stroke

(CN-NINM Trial)

Recruiting at 2 trial locations

Overseen By Maureen Ahiatsi, MsC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Spasticity, Sensory deficit, Hemineglect, Apraxia, Cognitive impairment, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

74 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

How does cranial nerve neuromodulation differ from other stroke treatments?

Cranial nerve neuromodulation for stroke is unique because it uses a noninvasive device placed on the tongue to stimulate specific cranial nerves, which can improve balance and gait when combined with physical therapy. This approach is different from traditional stroke treatments as it directly targets the brain's pathways through the cranial nerves, potentially enhancing rehabilitation outcomes without the need for drugs or invasive procedures. ^{1 2 3 4 5}

What is the purpose of this trial?

Following a stroke, persistent residual muscle weakness in the upper limb (UL) drastically impacts the individuals' quality of life and level of independence. Training interventions are recommended to promote UL motor recovery, and recent studies have shown that training must be tailored to each individual's recovery potential to maximise training gains. Complementary to training interventions, non-invasive brain stimulation devices (NIBS) can help support the provision of post-stroke care by modulating brain excitability and enhancing recovery. Among NIBS, cranial nerve non-invasive neuromodulation (CN-NINM) is gaining increasing attention in rehabilitation since it can directly and non-invasively stimulate the tongue's cranial nerves. The impulses generated can then reach the motor cortex, induce neuroplastic changes and support recovery. Promising results in various neurological populations have been observed, but in stroke, the efficacy of CN-NINM at improving arm motor recovery and brain plasticity is yet to be determined. This is what the present project intends to address, using a stratified randomized controlled trial, where participants in the chronic phase of a stroke will take part in a 4-week individualized training program of their affected UL in combination with real or sham CN-NINM. Before and after the intervention, participants will undergo clinical and neurophysiological evaluations to thoroughly evaluate CN-NINM-induced changes in UL motor function and associated neuroplastic changes. The proposed study will allow an in-depth evaluation of the effects of CN-NINM for an eventual implementation in clinics and at home to support optimal post-stroke recovery.

Research Team

Marie-Helene Milot, PhD

Principal Investigator

Université de Sherbrooke

Eligibility Criteria

This trial is for individuals in the chronic phase of stroke recovery who still have muscle weakness in their arm. They will participate in a 4-week program to improve arm function, which includes strength training and either real or sham cranial nerve stimulation.

Inclusion Criteria

I have some arm movement after my stroke.

I had a stroke that affected one side of my brain above the cerebellum.

I have been in recovery for more than 6 months.

Exclusion Criteria

I experience significant stiffness in my limbs.

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)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week individualized upper limb strength training program combined with real or sham cranial nerve non-invasive neuromodulation (CN-NINM)

4 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for changes in motor cortex excitability and upper limb function after the intervention

1 week

1 visit (in-person)

Treatment Details

Interventions

• Cranial nerve non-invasive neuromodulation

Trial Overview The study tests if stimulating the tongue's cranial nerves can help recover arm functions after a stroke. Participants are randomly placed into two groups: one receives actual neuromodulation while the other gets a placebo treatment, alongside personalized strength training.

Participant Groups

Group I: real CN-NINM + UL training group Experimental Treatment 2 Interventions

Upper limb strength training program combined to real CN-NINM

Group II: sham CN-NINM + UL training group Placebo Group 2 Interventions

Upper limb strength training program combined to sham CN-NINM

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

References

1. Canada pubmed.ncbi.nlm.nih.gov

Cranial Nerve Noninvasive Neuromodulation in Adults With Neurological Conditions: Protocol for a Scoping Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of noninvasive cranial nerve neuromodulation for nervous system disorders. [2018]

3. Scotland pubmed.ncbi.nlm.nih.gov

A novel neuromodulation technique for the rehabilitation of balance and gait: A case study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Sustained cortical and subcortical neuromodulation induced by electrical tongue stimulation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation of cranial nerves in cognition and disease. [2023]