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rTMS and Physical Therapy as a Clinical Service for People With Stroke
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2016
Longer than P75 for not_applicable stroke
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedNovember 24, 2017
November 1, 2017
5 years
October 28, 2016
November 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Box and Block Test
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)
Measured at baseline and after one week and two weeks of treatments
Secondary Outcomes (1)
MEP Amplitude
Measured at baseline and after one week and two weeks of treatments
Study Arms (1)
rTMS/PT
EXPERIMENTALThere will be only one group. All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2016
First Posted
November 3, 2016
Study Start
December 1, 2016
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
November 24, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share