rTMS and Physical Therapy as a Clinical Service for People With Stroke

Not Applicable

Withdrawn

• Conditions: Stroke
• Interventions: Device: repetitive transcranial magnetic stimulation (rTMS); Behavioral: Physical therapy

• Registration Number: NCT02954211
• Lead Sponsor: University of Minnesota

Brief Summary

The purpose of this study is to determine the characteristics that distinguish responders from nonresponders in people with stroke receiving rTMS combined with physical therapy to improve hand function. Investigators hypothesize that those who improve the most will be characterized by larger evoked brain signals in the stroke hemisphere and lower scores on the Beck Depression Inventory indicating less depression. Medications, sex, age, type of stroke, location of stroke, duration of stroke and baseline hand function will also be compared.

Detailed Description

Stroke is the leading cause of long-term disability in the United States. The disability stems not only from neurons killed by the stroke but also from neurons that become dormant from non-use and other reasons. The killed neurons cannot be recovered but the excitability of the dormant neurons can be improved. Increasing this excitability makes for easier voluntary recruitment of these neurons in patients, which translates to improved voluntary function and quality of life. Investigators have used repetitive transcranial magnetic stimulation (rTMS) for 10 years at the University of Minnesota in strictly a research mode. Investigators have found that some people benefit from the rTMS and some do not. Investigators also have observed that some people in prior studies have asked to receive rTMS after research participation had concluded and people were willing to pay for the service privately. However, until recently, investigators were not able to offer such service. Investigators have succeeded in getting approval from the University of Minnesota that allows rTMS combined with physical therapy to be given to outpatients with stroke who have physician referral. Patients will receive an initial block of five rTMS/physical therapy (rTMS/PT) treatments to the nonstroke hemisphere and, if early signs of benefit are shown, the patients will receive a second block of 5 additional treatments. If patients do not show improvement, an alternative approach involving rTMS to the stroke hemisphere will be offered. Patients will be informed in advance of the cost, that most insurance carriers will not cover the cost, and that patients would have to pay privately for treatments. The research component of this project involves collecting hand function data along with stroke characteristics to conduct a responder vs. nonresponder analysis. In this way, investigators would be providing clinical service to patients who desire this treatment while learning further the characteristics of those who benefit and those who do not, which would guide future treatment decisions.

Study Timeline

• Study First Submitted: 2016-10-28
• Study First Submitted QC: 2016-11-01
• Study First Posted: 2016-11-03
• Study Start: 2016-12
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-21
• Last Update Posted: 2017-11-24
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Stroke (ischemic or hemorrhagic, cortical or subcortical) of at least 5 days duration, at least 10 degrees of voluntary finger motion in the paretic hand but slower or not as far compared to the nonparetic hand, over 18 years of age

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Exclusion Criteria

• Seizure within the past two years, receptive aphasia, epileptogenic medication, major psychiatric disorder, metal in the head (dental permitted), pacemaker or other indwelling devices, other interfering comorbidities (fracture, etc), pregnant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rTMS/PT	repetitive transcranial magnetic stimulation (rTMS)	There will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.
rTMS/PT	Physical therapy	There will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.

Primary Outcome Measures

Name	Time	Method
Box and Block Test	Measured at baseline and after one week and two weeks of treatments	Determines the change from baseline to posttest in the number of 1-inch cubes that the person can grasp between finger and thumb and move from one box and dropped into an adjacent box in one minute (x3 trials)

Secondary Outcome Measures

Name	Time	Method
MEP Amplitude	Measured at baseline and after one week and two weeks of treatments	Determines the change from baseline to posttest in the average peak-to-peak motor evoked potential (MEP) amplitude from target muscle of 10 TMS pulses at 130% of threshold.