Using patterned non-invasive brain stimulation (iTBS) to improve hand strength after chronic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Age \>=21 years old of any race or gender
2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 3 months from stroke onset
3. Unilateral arm weakness measured by FM-UM scale \<= 62 out of 66
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. 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).
5. 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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• kTMP-Enhanced Arm Rehabilitation in Chronic Stroke (KULMINATE) Pilot

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• Optimizing low-intensity focused ultrasound to improve arm movement after stroke

  This research will try low-intensity focused ultrasound on the motor cortex to see if different power levels and timing improve arm strength and motor learning in people at least six months after a first stroke.

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• Intermittent Theta Burst Stimulation (iTBS) to improve upper‑limb movement after chronic stroke

  This study will test if brief non‑invasive brain stimulation (iTBS) applied to the affected motor cortex plus regular physical therapy can improve arm and hand movement in adults who had a stroke more than six months earlier.

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• Intermittent Theta Burst Stimulation for lower limb recovery after chronic stroke

  This trial tests whether intermittent Theta Burst Stimulation (iTBS) of the cerebellum, combined with physical therapy, can improve leg movement and walking in people with chronic stroke.

  Recruiting Danderyd Hospital · Stockholm · NCT07073235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.