RECRUITING

The Effect of Non-invasive Brain Stimulation rTMS on Hand Muscles in Chronic Stroke Patients.

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Conditions

StrokeStroke PatientsArm Weakness as a Consequence of StrokeBrain StimulationTranscranial Magnetic Stimulation RepetitiveTranscranial Magnetic StimulationMotor LearningChronic Stroke PatientsChronic Stroke Survivorsarm weaknesschronic stroke

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is about using a brain stimulation technique called rTMS (Repetitive Transcranial Magnetic Stimulation) to help improve hand muscles in people who had a stroke. Researchers want to understand how this device can help stroke patients use their hands better.

Official Title

Evaluation of 3 Patterned rTMS Stimulation Dosage on Corticospinal Excitability and Motor Learning in Stroke Patients

Quick Facts

Study Start:2025-06-09
Study Completion:2027-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06765642

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age \>=21 years old of any race or gender
  2. 2. First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from stroke onset
  3. 3. Unilateral arm weakness measured by FM-UM scale \<= 62/64
  4. 4. Inducible rest motor threshold and testing motor threshold recorded from the affected first dorsal interosseous (FDI) muscle from the study subject
  1. 1. Bilateral strokes (infarcts and/or hematoma)
  2. 2. Other co-existent neuromuscular disorders affecting upper extremity motor impairment.
  3. 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. 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. 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. 6. Presence of any MRI/rTMS risk factors including but not limited to:
  7. 1. an electrically, magnetically, or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system.
  8. 2. a non-fixed metallic part in any part of the body, including a previous metallic injury to the eye.
  9. 3. history of seizure disorder before stroke or seizure after stroke.
  10. 4. preexisting scalp lesion or bone defect or hemicraniectomy.
  11. 6. Concurrent enrollment in another interventional stroke recovery study. 7. Concerns that the subject cannot comply with study procedures and visits. 8. Pregnant individuals.

Contacts and Locations

Study Contact

Wuwei Feng, MD
CONTACT
919 681 1700
wayne.feng@duke.edu
Megan N Gonzalez, MS
CONTACT
9196687597
megan.gonzalez@duke.edu

Principal Investigator

Wayne Feng, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Medical Center
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Wayne Feng, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09
Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

  • stroke
  • arm weakness
  • arm weakness as a consequence of stroke
  • stroke patients
  • transcranial magnetic stimulation
  • transcranial magnetic stimulation repetitive
  • motor learning
  • chronic stroke
  • chronic stroke patients
  • chronic stroke survivors

Additional Relevant MeSH Terms

  • Stroke
  • Stroke Patients
  • Arm Weakness as a Consequence of Stroke
  • Brain Stimulation
  • Transcranial Magnetic Stimulation Repetitive
  • Transcranial Magnetic Stimulation
  • Motor Learning
  • Chronic Stroke Patients
  • Chronic Stroke Survivors