NCT06998485 Substrates for Post-Stroke Arm Rehabilitation
| NCT ID | NCT06998485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Stroke Rehabilitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-07 |
| Primary Completion | 2030-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-10-07 with a primary completion date of 2030-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Difficulty moving the arm is very common and a major cause of disability after stroke. Although rehabilitation therapies (i.e., occupational and physical therapy) are the most common treatments used to improve arm motor function, it remains unknown how therapy actually changes brain pathways after stroke. This project seeks to generate fundamental knowledge about brain pathways that allow people to move their arm after stroke and how these pathways change with rehabilitation; we expect this knowledge to translate to new therapies to reduce stroke-related disability. We plan to enroll N = 50 patients with moderate to severe difficulty moving their arm after ischemic or hemorrhage stroke during the subacute period (3 to 6 months post stroke) into either 30 hours over 6 weeks of Arm Basis Training (a protocolized form of occupational therapy targeting motor control) or usual care. We will perform kinematic motor assessments, neuroimaging, and neurophysiology before and after therapy in order to test the hypothesis that intensive, target training improves arm motor control and induces corresponding anatomical and physiological changes of associated brain pathways.
Eligibility Criteria
Inclusion Criteria: * first time unilateral ischemic or hemorrhagic stroke occurring within the 3-6 months * upper extremity motor impairment as measured by the Upper Extremity Fugl-Meyer Assessment (UE-FMA) Score \<= 44 * ability to participate in a 6-week intensive upper extremity intervention in English as determined by a licensed occupational therapist. Exclusion Criteria: * bilateral stroke * unstable medical status affecting functional status * pre-stroke upper extremity injury or conditions that limited use * visual or auditory impairment limiting ability to participate in study procedures * significant aphasia (NIHSS sub-item 9 \> 1) or cognitive (NIHSS 1a or 1b or 1c \> 1) deficits * known or expected inability to maintain follow-up through the study intervention and post- assessment * contraindications to MRI * contraindications to TMS * known history of uncontrolled seizure disorder.
Contact & Investigator
David J Lin, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT06998485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke Rehabilitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06998485 currently recruiting?
Yes, NCT06998485 is actively recruiting participants. Contact the research team at celambert@mgh.harvard.edu for enrollment information.
Where is the NCT06998485 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06998485 clinical trial?
NCT06998485 is sponsored by Massachusetts General Hospital. The principal investigator is David J Lin, MD at Massachusetts General Hospital. The trial plans to enroll 50 participants.
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