cHMC rTMS + Upper Limb Training Training for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH
Stroke
Novel rTMS Approach - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.

Week 7
Change Resting State Functional Magnetic Resonance Imaging(rsfMRI)
Change in excitability of cortical and corticospinal physiology (TMS)
Month 1
Change in ABILHAND
Change in Bimanual Assessment Measure (BAM)
Change in Bimanual Grip Force Modulation Task
Change in Upper Extremity Fugyl-Meyer Score (UEFM)
Change in Wolf Motor Function Test (WMFT)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

cHMC rTMS + Upper Limb Training Training
1 of 2
Sham rTMS + Upper Limb Training Training
1 of 2
Experimental Treatment
Non-Treatment Group

18 Total Participants · 2 Treatment Groups

Primary Treatment: cHMC rTMS + Upper Limb Training Training · Has Placebo Group · Phase < 1

cHMC rTMS + Upper Limb Training Training
Device
Experimental Group · 1 Intervention: Novel rTMS Approach · Intervention Types: Device
Sham rTMS + Upper Limb Training Training
Device
ShamComparator Group · 1 Intervention: Sham rTMS Approach · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (0 weeks and 2 weeks), after intervention(up to 7 weeks) and after end of 1 month of follow-up.

Trial Background

Prof. Ela B. Plow, Assistant Professor
Principal Investigator
The Cleveland Clinic
Closest Location: Lerner Research Institute, Cleveland Clinic Foundation · Cleveland, OH
Photo of Cleveland  1Photo of Cleveland  2Photo of Cleveland  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Stroke
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 to 90 years old.
You have had a stroke within the past 6 months.
You have a score of < 11 out of 14 on the hand section of the UEFM.
You have at least 10 degrees of active wrist extension, 10 degrees of active thumb abduction/extension, and 10 degrees of active extension in at least 2 additional digits.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.