Multifocal theta-burst stimulation to boost arm recovery after stroke
Advancing Stroke Rehabilitation Through Multifocal Network-based Theta-burst Stimulation and Assistive Technology: Enhancing Upper Limb Motor Learning: A Single-center, Randomized, Sham-controlled Study With Parallel Groups.
This trial tests whether sequential intermittent theta-burst brain stimulation to motor and parietal areas, combined with tablet-based arm training, can improve arm movement in adults with chronic stroke-related weakness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | School of Health Sciences Geneva Academic / other |
| Locations | 1 site (Carouge, Canton of Geneva) |
| Trial ID | NCT07439367 on ClinicalTrials.gov |
What this trial studies
The study delivers neuronavigated intermittent theta-burst stimulation (iTBS) sequentially to the affected hemisphere's primary motor cortex and superior parietal lobule, paired with tablet-based upper limb exercises, and compares active stimulation to sham. Eligible participants are adults at least six months after a first unilateral ischemic or hemorrhagic stroke with moderate residual arm weakness (FMA-UE 29–57). The intervention aims to enhance parietal–motor network functional connectivity to promote neuroplasticity and motor relearning. Outcomes focus on changes in upper-limb function following the combined neuromodulation and training program.
Who should consider this trial
Good fit: Adults aged 18 or older who are at least six months after a first ischemic or hemorrhagic stroke, have unilateral upper-limb weakness with FMA-UE scores of 29–57, and can follow study procedures.
Not a fit: Patients with severe paralysis (FMA-UE below 29), uncontrolled epilepsy, recent botulinum toxin injections, implanted metallic or electronic devices near the stimulation site, or who experience a recurrent stroke are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If successful, this approach could strengthen brain network connectivity to improve arm strength and day-to-day use for people living with chronic post-stroke weakness.
How similar studies have performed: Previous rTMS and monofocal iTBS trials over motor cortex have shown mixed but promising effects on chronic stroke motor recovery, while multifocal parietal-plus-motor iTBS is a relatively new and less-tested strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For Stroke Participants: * Age ≥ 18 years * First-ever ischemic or hemorrhagic stroke * Time since stroke ≥ 6 months * Unilateral upper limb hemiparesis * Fugl-Meyer Assessment Upper Extremity (FMA-UE) score between 29 and 57 * Modified Ashworth Scale score \< 2 at elbow, wrist, or finger flexors * Manual muscle testing ≥ 3/5 in proximal upper limb muscles (deltoid, biceps, triceps, wrist pronators/supinators) * Ability to understand and follow study procedures * Provided written informed consent For Healthy Participants: * Age ≥ 18 years * No history of neurological disease * Ability to understand and follow study procedures * Provided written informed consent Exclusion Criteria: For Stroke Participants: * Second stroke occurring during the study period * Botulinum toxin injection within 3 months prior to study start * History of one or more epileptic seizures * Metallic object near the stimulation site * Implanted electronic or metallic devices (e.g., pacemaker, neurostimulator) incompatible with TMS * Severe comorbid conditions affecting the upper limb (traumatic, rheumatologic, osteoarticular, or neurodegenerative disorders) * Pregnancy * Delirium or impaired vigilance * Inability to participate in one-hour treatment sessions * Inability to comply with study procedures (e.g., language barrier, psychological disorder, dementia) * Current or past substance abuse, including excessive alcohol consumption * Participation in another interventional clinical trial within 30 days prior to enrollment For Healthy Participants: * Severe musculoskeletal or neurological condition affecting the non-dominant upper limb * Pregnancy * Delirium or impaired vigilance * Inability to participate in one-hour treatment sessions * Inability to comply with study procedures * Current or past substance abuse, including excessive alcohol consumption * Participation in another interventional clinical trial within 30 days prior to enrollment
Where this trial is running
Carouge, Canton of Geneva
- University School of Health ▪ HES-SO Genève — Carouge, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Pierre Nicolo, PhD
- Email: pierre.nicolo@hesge.ch
- Phone: +41792633543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.