Using Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function After a Stroke

NCT05370274 | Completed DMC

• 1 other identifier: 2022-4609
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Exercise; Upper limb; Motor recovery; Pain; Cranial nerve non-invasive neuromodulation

Outcome Measures

Primary Outcomes (5)

• Recruitment rate for the project

  This outcome will be compiled by the total number of participants recruited, divided by the average number of months recruiting.

  Information will be assessed at the end of the recruitment period, at week 28

• Refusal to participate and the reasons

  Participants refusal to participate will be assessed by number of participants who declined to participate in the project and the associate reasons

  Information will be assessed throughout the project recruitment period (average of 7 months)

• Dropped out rate of the project in percent and the reasons

  Dropped out rate will be collected by the number of participants who dropped out of the project divided by the total number of participants recruited X 100%. Reasons for each drop out will also be collected.

  Information will be assessed through project completion, an average of 9 months

• Adherence to the intervention (training program and CN-NINM) in percent

  Adherence to the intervention will be calculated by the number of training sessions completed out of the total number expected X 100%

  Information will be assessed through study completion, an average of 9 months

• Number of participants with CN-NINM-related adverse events as assessed by a questionnaire

  Adverse events will be assessed with a questionnaire that will provide a number and percentage of participants who have experienced adverse events as well as allowing collecting information on symptoms that may be related to CN-NINM.

  Information will be be assessed through study completion, an average of 9 months

Secondary Outcomes (6)

• Change in pain intensity on the CoVAS

  The assessments will be done at the baseline and just after the 20 minutes of application of the CN-NINM.

• Change in UL functional performance on the Wolf Motor Function Test

  The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.

• Change in UL motor function on the Fugl-Meyer Stroke Assessment Scale

  The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.

• Change in affected grip strength on the JAMAR dynamometer

  The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.

• Change in manual dexterity on the Box and Block test

  The assessments will be done at the baseline and in the week after completion of the training program and CN-NINM.

Study Arms (2)

strength training intervention

EXPERIMENTAL

Strength training of the affected upper limb in chronic stroke survivors

Procedure: Strength training intervention

Cranial nerve non-invasive neuromodulation (CN-NINM)

EXPERIMENTAL

CN-NINM will be applied during each session of the strength training intervention

Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)

Interventions

Strength training intervention PROCEDURE

The strength training program will last 4 weeks (3 X/week, 60 minutes). Using dead weights, the 1RM (i.e. the maximal load that an individual can lift once) will be estimated by the 10RM in order to avoid tendino-muscular injuries and fatigue. The 10RM will be determined for the muscles playing a key role in the functional performance of the upper limb (the wrist extensors and the elbow and shoulder flexors). In addition, the grip muscles of the affected hand will be trained with a JAMAR® dynamometer. Training will start at 50% of 1RM and progress by 10% each week to reach 80% of 1RM by week 4. The same gradation of intensity will be applied to the grip muscles. The training will begin and end by a 5-minute warm-up and relaxation period comprising of active movements of the trained muscles.

strength training intervention

Cranial nerve non-invasive neuromodulation (CN-NINM) PROCEDURE

During each strength training session, the CN-NINM will be applied, with the help of a portable stimulator comprising a network of 18 electrodes, directly on the tongue of the participants for 20 minutes. The participants will hold the CN-NINM in place by pressing their tongue upwards. The CN-NINM will generate high-frequency pulses (50 μsec to 150 Hz), and the intensity of the stimulus will be set by each participant to a comfortable level of sensation, similar to the sensation in the mouth of a soft drink.

Cranial nerve non-invasive neuromodulation (CN-NINM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be ≥18 years old;
• Have had a single supratentorial stroke;
• Be in a chronic stroke phase (\>6 months);
• Present motor recovery in the upper limb (UL) (Fugl-Meyer Stroke Assessment \[FMA\] score ≥20/66);
• Have completed any rehabilitation treatment.

You may not qualify if:

• A significant spasticity at the affected upper limb (score \> 3 on the modified Ashworth scale);
• A major sensory deficit at the affected upper limb (a score ≤25/34 on the Nottingham Sensory Assessment and a score \<6 on the evaluation of the vibration threshold);
• A presence of hemineglect (score ≥±0. 083 on the Line Cancellation test);
• An apraxia (score \>2.5 on the Alexander Test);
• The presence of a neurological disorder other than a stroke;
• Concomitant orthopaedic problem at the affected UL;
• Cognitive impairment (Mini-Cog score \<2/5) and
• Any contraindication to CN-NINM.

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche sur le vieillissement

Sherbrooke, Quebec, J1H4C4, Canada

Location

Related Publications (2)

• Ahiatsi M, Milot MH, Flaive A, Leonard G. Tasting pain-relief through tongue stimulation: results from a feasibility study looking into the use of cranial nerve non-invasive neuromodulation in healthy individuals and chronic poststroke patients. BMC Neurol. 2026 Jan 2. doi: 10.1186/s12883-025-04498-6. Online ahead of print.

  PMID: 41484860 DERIVED

• Ahiatsi M, Leonard G, Riesco E, Girard MC, Milot MH. A feasibility study on the use of cranial nerve non-invasive neuromodulation to improve affected arm function in people in the chronic stage of a stroke. BMC Neurol. 2025 May 16;25(1):208. doi: 10.1186/s12883-025-04213-5.

  PMID: 40380081 DERIVED

MeSH Terms

Conditions

Stroke; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-Hélène Milot, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

• Guillaume Léonard, Ph.D.

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study model is a pre/post intervention pilot study.

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 11, 2022
• Study Start: June 27, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)