REALISEHigh-Dose rTMS for Motor Recovery in Chronic Stroke
Transcranial Magnetic Stimulation
Brain Diseases+8
+ Cardiovascular Diseases
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: June 9, 2025
Actual date on which the first participant was enrolled.This study explores a new approach to help individuals who have experienced a chronic stroke improve their movement abilities. It tests a therapy called Transcranial Magnetic Stimulation (TMS), which uses magnetic pulses to stimulate the brain. The study examines different doses of a specific type of TMS called intermittent theta-burst stimulation (iTBS) to see if it can enhance the brain's ability to change and recover, thereby improving motor skills. The participants in the study are people who have had a stroke and are experiencing long-term difficulties with movement. This research is important because it could lead to better recovery treatments for those living with the ongoing effects of a stroke. Participants in the study receive TMS treatment, which is delivered in two main ways: either as a conventional dose of 600 pulses or as a higher dose of 2400 pulses. The high-dose treatment is further divided into focusing on one specific area of the brain or spreading across four areas. The treatment aims to increase activity in the part of the brain that controls movement, which might help improve motor learning and performance. The study investigates how these different doses and methods affect the brain's excitability and the participants' ability to learn and perform motor tasks. The potential benefit is improved movement and recovery, though the study will carefully monitor for any risks associated with the higher doses of stimulation.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.26 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 21 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Duke University Medical Center
Durham, United StatesOpen Duke University Medical Center in Google Maps