Status:
COMPLETED
A Novel Approach for Brain Stimulation in Severe Stroke
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
American Heart Association
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their ...
Detailed Description
In a pilot, randomized clinical trial, 24 stroke patients with moderate/severe impairments will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or rTMS) to one of ...
Eligibility Criteria
Inclusion
- chronic phase (≥6 months) after index stroke
- moderate or severely impaired (UEFM ≤42)
- have either extensive damage to ipsilesional pathways (MEP-), or, have one of the following: less than 10 degrees active wrist extension, less than 10 degrees active thumb extension/abduction, less than 10 degrees active extension in at least 2 additional digits (i.e. will not meet minimum Constraint-Induced Movement Therapy \[CIMT\] criteria).
- medically stable
Exclusion
- cerebellar stroke
- brainstem stroke
- bilateral strokes affecting sensorimotor structures
- severe cognitive impairment
- substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale \>3)
- severe contracture
- participation in outpatient or Botox therapy within 2 months
- exclusion criteria for TMS and MRI (metal implant in head, H/O seizures, alcohol or substance abuse, intake of medications contraindicated with TMS, cardiac pacemaker or programmable implant).
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03868410
Start Date
April 1 2019
End Date
July 13 2023
Last Update
June 5 2025
Active Locations (1)
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1
Lerner Research Institute; Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195