Newsletter

Stay up to date on all things stroke. Sign up and we’ll send you the latest news, resources, scientific breakthroughs, events, tips, and much more.

Share this post on your profile with a comment of your own:

Successfully Shared!

View on my Profile

A Novel Approach for Brain Stimulation in Severe Stroke

June 19, 2019

Overview

The long-term goal of this clinical trial is to develop upper limb rehabilitation interventions that stroke survivors can use. It is specifically being conducted for survivors with more severe limitations of their affected upper limb.

 

This study will use a method of non-invasive brain stimulation combined with upper limb training given for 15 visits over a period of 5 weeks.

 

The study will include the following site visits:

 

  • Eligibility Screening and Informed Consent Visit
  • An MRI visit
  • Two testing visits in which motor function of the upper limb and neurophysiology will be measured
  • Fifteen intervention visits during which patients will receive upper limb training combined with non-invasive brain stimulation
  • Repeat testing of motor function of the upper limb and neurophysiology
  • Repeat MRI testing
  • A follow-up visit completed 3 months after the completion of interventions

 

Study Information

This is an interventional, quadruple-blind, randomized, parallel assignment for the primary purpose of treatment after a severe stroke. There is an estimated 24 participants. The study began on April 1, 2019 and is expected to be completed by September 30, 2021.

 

Inclusion Criteria

 

  • Chronic phase (≥6 months) after index stroke
  • Moderate or severely impaired (UEFM ≤42) with extensive damage to ipsilesional pathways (MEP-)
  • Able to perform the reaching-response time task
  • Medically stable

 

Exclusion Criteria

 

  • Cortical stroke affecting motor areas (identified using T1-weighted MRI)
  • Brainstem stroke
  • Bilateral strokes
  • Severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≤ 24)
  • Substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale >3)
  • Severe contracture
  • Participation in outpatient or Botox therapy within 3 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)

 

Location

You may participate in this study at the Lerner Research Institute; Cleveland Clinic Foundation in Cleveland, Ohio, United States, 44195. If you have any questions or concerns you may contact Morgan Widina, MS at 866-449-1394 or at widinam@ccf.org.

 

Sponsors/Collaborators

This study is sponsored by The Cleveland Clinic and collaborated by the American Heart Association. Ela Plow, PhD of the Lerner Research Institute; Cleveland Clinic Foundation serves as the Principal Investigator.

Clinical Trials

View All

Constraint Induced Movement Therapy Post Stroke

This is a 6 week study with three assessments to compare the effect of constraint induced movement therapy (CIMT)…

Feasibility of Better Living After Stroke Through Technology

The investigators of this study aim to evaluate the feasibility of Better Living After Stroke through Technology…

Mechanics-based Intervention to Improve Post-stroke Stability

Every year, about 15,000 American Veterans suffer from a stroke. After a stroke the ability to walk is a top goal…

Assessing Leg Control in People With Chronic Stroke

The Fugl-Meyer assessment (FMA) is the “Gold Standard” for the assessing individuals with brain…

Hip Hop Stroke: School-based Public Stroke Education

The program Hip Hop Stroke 2.0 helps schools fulfill NYS health education requirements. Children are also taught to…

Sensory-Motor Rehabilitation Post Stroke

The study will research early rehabilitation stroke for motor relearning, reducing ankle impairments and improving…

Stroke Ready – Optimizing Acute Stroke Care

The goal of this clinical trial is to increase acute stroke treatment rates in Flint, Michigan through a…

Stroke Rehabilitation Using BCI Technology

The purpose of this clinical trial is to see if functional muscle stimulation, directed by electroencephalogram…

Send this to a friend