Using patterned non-invasive brain stimulation (iTBS) to improve hand strength after chronic stroke
Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients
This trial will test whether a high-dose patterned non-invasive brain stimulation (iTBS) can help people with chronic stroke regain hand muscle strength and motor control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | Aducanumab, Lecanemab, Donanemab |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06765642 on ClinicalTrials.gov |
What this trial studies
Researchers will compare a conventional intermittent theta-burst stimulation (iTBS600) protocol to two high-dose protocols (FiTBS2400 applied to one focal site and DiTBS2400 applied across four sites) delivered to the damaged hemisphere in people at least six months after a first stroke. Outcomes include measures of corticospinal excitability and motor performance of the affected hand, with motor thresholds recorded from the first dorsal interosseous muscle. The study uses repeated non-invasive transcranial magnetic stimulation sessions and standardized motor testing to quantify neuromotor changes. Results aim to determine whether higher total pulse doses or broader versus focal stimulation produce greater neural plasticity and functional gains.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 or older with a single ischemic or hemorrhagic stroke at least six months prior, unilateral arm weakness (FM-UE score ≤62/64), and an inducible motor threshold from the affected FDI muscle.
Not a fit: Patients with bilateral strokes, other neuromuscular disorders affecting the arm, uncontrolled neuropsychiatric disease or dementia, or uncontrolled hypertension are unlikely to be eligible or to receive benefit.
Why it matters
Potential benefit: If successful, this approach could increase hand strength and improve functional use of the affected arm by enhancing corticospinal plasticity.
How similar studies have performed: Previous rTMS and iTBS studies after stroke have shown promising but mixed motor benefits, while the specific high-dose focal versus diffuse iTBS protocols tested here are relatively novel and less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>=21 years old of any race or gender 2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from stroke onset 3. Unilateral arm weakness measured by FM-UM scale \<= 62/64 4. Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject Exclusion Criteria: 1. Bilateral strokes (infarcts and/or hematoma) 2. Other co-existent neuromuscular disorders affecting upper extremity motor impairment. 3. History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study. 4. History of confirmed dementia or taking the following dementia drugs, such as Donepezil, Rivastigmine, Galantamine, Memantine, Aducanumab, Lecanemab, Donanemab that affecting their ability to follow study procedure. 5. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later). 6. Presence of any MRI/rTMS risk factors including but not limited to: 1. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system. 2. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye. 3. history of seizure disorder before stroke or seizure after stroke. 4. preexisting scalp lesion or bone defect or hemicraniectomy. 6\. Concurrent enrollment in another interventional stroke recovery study. 7. Concerns that the subject cannot comply with study procedures and visits. 8. Pregnant individuals.
Where this trial is running
Durham, North Carolina
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Wayne Feng, MD — Duke University
- Study coordinator: Wuwei Feng, MD
- Email: wayne.feng@duke.edu
- Phone: 919 681 1700
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.