rTMS and Physical Therapy as a Clinical Service for People With Stroke
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02954211|
Recruitment Status : Withdrawn (Researcher left University)
First Posted : November 3, 2016
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: repetitive transcranial magnetic stimulation (rTMS) Behavioral: Physical therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||rTMS and Physical Therapy as a Clinical Service for People With Stroke|
|Estimated Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
There will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.
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.
- Box and Block Test [ Time Frame: 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)
- MEP Amplitude [ Time Frame: 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.