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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people regain arm strength after a stroke using cranial nerve non-invasive neuromodulation (CN-NINM). This technique stimulates nerves in the tongue to send signals to the brain, potentially boosting recovery and brain healing. Participants will receive either real or sham nerve stimulation along with arm strength training. The trial seeks individuals who had a stroke over six months ago, still have some arm movement, and are not currently in other rehabilitation programs. The goal is to determine if this treatment can eventually be used in homes and clinics to improve post-stroke recovery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke survivors.

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.

What prior data suggests that cranial nerve non-invasive neuromodulation is safe for stroke recovery?

A previous study used a technique called cranial nerve non-invasive neuromodulation (CN-NINM) alongside an arm strengthening program. This study suggested that the combination is feasible and may improve arm function in stroke survivors. Another study examined CN-NINM's effectiveness in enhancing movement and found it might also reduce pain.

Overall, CN-NINM is considered safe. As a non-invasive method, it does not involve surgery or entering the body, reducing the risk of serious side effects. So far, these studies have reported no major problems related to CN-NINM.

These findings suggest that CN-NINM could be a well-tolerated option for stroke recovery. However, more research is needed to fully understand its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cranial nerve non-invasive neuromodulation (CN-NINM) for stroke recovery because it offers a novel approach to enhancing upper limb strength. Unlike traditional stroke rehabilitation methods, which often rely on physical therapy and medication to improve motor skills, CN-NINM stimulates cranial nerves directly without the need for surgery or drugs. This method leverages the body's natural pathways to potentially accelerate recovery and improve motor function more effectively. By combining this technique with strength training, the hope is to see faster and more significant improvements in stroke patients' ability to regain use of their upper limbs.

What evidence suggests that cranial nerve non-invasive neuromodulation is effective for stroke recovery?

Research shows that cranial nerve non-invasive neuromodulation (CN-NINM) might improve arm function in people recovering from a stroke. In this trial, participants will be divided into two groups: one will receive real CN-NINM combined with upper limb strength training, while the other will receive sham CN-NINM with the same training. Previous studies have shown that stroke survivors using CN-NINM with arm exercises experienced better arm movement. Another study found that CN-NINM might also aid walking and balance. This treatment works by gently stimulating nerves in the tongue, leading to brain changes that aid recovery. While results are promising for various brain-related conditions, researchers are still determining its effectiveness specifically for arm recovery after a stroke. ^{1 2 6 7 8}

Who Is on the Research Team?

Marie-Helene Milot, PhD

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12082858/

A feasibility study on the use of cranial nerve non-invasive ... This study suggests that CN-NINM combined with an arm strengthening program is feasible and may improve arm function in chronic stroke survivors.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05370274

Study Details | NCT05370274 | Using Cranial Nerve Non- ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10046557/

Noninvasive Brain Stimulation for Neurorehabilitation in Post ... The literature has shown that tVNS has the potential to enhance central noradrenergic activity and improve clinical outcomes in stroke. Studies ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877065718308960

Cranial nerve non-invasive neuromodulation improves gait ... The objective of this study was to determine the efficacy of CN-NINM in improving gait and balance in a pilot randomised controlled trial in stroke survivors ...

5. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(25)00189-8/abstract

The Effectiveness of Noninvasive Brain Stimulation ... Of the 42 outcomes assessed, two (4.7%) were judged as high-certainty evidence and referred to the lack of superiority of combining NIBS, especially ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK299239/

Cranial Nerve Noninvasive Neuromodulation - NCBI - NIH CN-NINM is a multi-targeted rehabilitation therapy that initiates the recovery of multiple damaged or suppressed brain functions affected by neurological ...

7. e-bnr.org e-bnr.org/DOIx.php?id=10.12786/bn.2024.17.e5

Update on Non-invasive Brain Stimulation on Stroke Motor ... This literature review endeavors to explore and present recent findings of NIBS techniques on poststroke motor impairment.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1878747924000230

The evolution of neuromodulation for chronic stroke Overall, these results are promising and open the door to the use of DBS for functional recovery post-stroke even in the absence of other movement disorders.