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

NCT02954211 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-11-24

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

repetitive transcranial magnetic stimulation (rTMS)

rTMS can be given to either the stroke or nonstroke hemisphere. For the nonstroke hemisphere, priming rTMS will be given to the optimal spot at an intensity of 90% of threshold at a frequency of 6 Hz for a 5-s ON period followed by 25-s OFF period. The ON-OFF cycling continues for 10 min. Principal rTMS follows priming and is applied at the same intensity at 1 Hz continuously for 10 minutes. The rationale for 6-Hz priming is to make the 1-Hz principal rTMS more effective. The after-effects of the principal rTMS are inhibition of the underlying neurons in the nonstroke hemisphere, which has a facilitating effect on the stroke hemisphere. For the stroke hemisphere, rTMS will involve 6-Hz stimulation at the optimal spot at an intensity of 90% of threshold at a frequency of 6 Hz for a 5-s ON period followed by a 25-s OFF period. The ON-Off cycling continues for 10 minutes. With either form of rTMS, the desired effects of the rTMS are facilitation of the neurons in the stroke hemisphere.

BEHAVIORAL

Physical therapy

Following the total rTMS treatment and a 3-minute break, physical therapy treatment will commence. The physical therapy treatment will consist of 15 minutes of finger movement tracking training followed by 15 minutes of virtual hand exercises. The tracking involves placing an small device on the weak hand that records finger motion and moving the index finger into finger extension and flexion to track a computer screen cursor as accurately as possible along a target track. The virtual hand exercises involve placing the weak hand in front of a computer with a program that will show a virtual hand and some blocks on a computer screen. The patient will attempt to stack the blocks by doing active hand movements that control the virtual hand. Another virtual hand exercise involves using the thumb and index finger to pluck petals from a virtual flower shown on the screen. There are further exercises like this.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-31
Completion
2021-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954211 on ClinicalTrials.gov