A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Stroke

In brief

The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stroke survivors with moderate to severe impairment. This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks. The study will include the following site visits: * Eligibility Screening and Informed Consent Visit * Baseline testing (4 visits total): 1 visit each for MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * Repeat baseline testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * 12 intervention visits during which patients will receive upper limb therapy in conjunction with non-invasive brain stimulation * Repeat testing (4 visits total) of MRI, upper limb and bimanual motor function test, bimanual motor control, and neurophysiology related to control of the upper limbs * A follow-up visit 1 month after the completion of interventions

Key facts

Study ID

NCT05381740

Run by

The Cleveland Clinic

People needed

17

Starts

2022-03-08

Expected to finish

2024-01-01

Last updated by the study team

2024-06-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-90 yrs
• ≥6 months since first clinical stroke
• Impairment of the paretic hand, indicated by a score of <= 11 out of 14 on the hand section of UEFM
• Sufficient range of motion in the wrist and fingers for functional task practice: have at least 10 degrees active wrist extension, 10 degrees active thumb abduction/extension, and 10 degrees active extension in at least 2 additional digits
• Sufficient active shoulder and elbow movement to volitionally position the paretic hand in the workspace for table-top task practice

You may not qualify if…

• Brainstem or cerebellar stroke
• Bilateral strokes or multiple strokes affecting sensorimotor structures
• Cognitive impairment (Mini-Mental State Examination <24)
• Severe impairment of the paretic hand that limits functional task practice (UEFM hand score < 4 out of 14)
• Severe spasticity (Modified Ashworth Scale >3) or upper limb contracture
• Occupational therapy or upper limb Botox completed ≤ 2 months prior
• Contraindications to TMS or MRI (e.g. metal implant in head, seizure history, cardiac pacemaker)

Where it is running

• Lerner Research Institute, Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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