Using Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function After a Stroke
CompletedNot applicableNCT05370274
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Brief summary (from the registry)
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.
Study details
- Official title
- Cranial Nerve Non-invasive Neuromodulation to Improve Pain and Upper Extremity Function in Individuals in the Chronic Phase of Stroke: a Pilot Feasibility Study
- Conditions
- Interventions
- Procedure: Strength training intervention
- Procedure: Cranial nerve non-invasive neuromodulation (CN-NINM)
- Sponsor
- Université de Sherbrooke
- Start date
- 2022-06-27
- Primary completion
- 2023-06-21
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Be ≥18 years old; 2. Have had a single supratentorial stroke; 3. Be in a chronic stroke phase (\>6 months); 4. Present motor recovery in the upper limb (UL) (Fugl-Meyer Stroke Assessment \[FMA\] score ≥20/66); 5. Have completed any rehabilitation treatment. Exclusion Criteria: 1. A significant spasticity at the affected upper limb (score \> 3 on the modified Ashworth scale); 2. 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); 3. A presence of hemineglect (score ≥±0. 083 on the Line Cancellation test); 4. An apraxia (score \>2.5 on the Alexander Test); 5. The presence of a neurological disorder other than a stroke; 6. Concomitant orthopaedic problem at the affected UL; 7. Cognitive impairment (Mini-Cog score \<2/5) and 8. Any contraindication to CN-NINM.
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Centre de recherche sur le vieillissement | Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05370274