- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02954211
rTMS and Physical Therapy as a Clinical Service for People With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rTMS/PT
There will be only one group.
All participants will receive 10 treatments of active repetitive transcranial magnetic stimulation combined with physical therapy.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Measured at baseline and after one week and two weeks of treatments
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Measured at baseline and after one week and two weeks of treatments
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- rTMS/PT/Stroke
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.RecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, CryptogenicSingapore, Philippines
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Vanderbilt University Medical CenterPatient-Centered Outcomes Research Institute; University of Alabama at BirminghamEnrolling by invitationStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Engagement, Patient | Stroke HemorrhagicUnited States
-
University of MinnesotaAmerican Occupational Therapy FoundationRecruitingStroke | Stroke Sequelae | Stroke Hemorrhagic | Stroke IschemicUnited States
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); Michael Smith Foundation for...RecruitingStroke | Stroke, Ischemic | Stroke Hemorrhagic | Chronic StrokeCanada
-
University of CincinnatiMedical University of South Carolina; University of California, Los Angeles; University...RecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke HemorrhagicUnited States
-
Turkish Stroke Research and Clinical Trials NetworkElectroCore INC; Turkish Neurological SocietyCompletedStroke | Stroke, Ischemic | Stroke, Acute | Stroke, HemorrhagicTurkey
-
University of LiegeCompletedStroke, Acute | Stroke Hemorrhagic | Stroke, ComplicationBelgium
Clinical Trials on repetitive transcranial magnetic stimulation (rTMS)
-
Centre Hospitalier Universitaire de NiceCompletedPost-traumatic Stress DisorderFrance
-
MGH Institute of Health ProfessionsNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
Krystal Parker, PhDRecruitingDepression | Schizophrenia | Parkinson Disease | Bipolar Disorder | Autism Spectrum DisorderUnited States
-
Brigham and Women's HospitalBeth Israel Deaconess Medical Center; Mclean HospitalNot yet recruitingObesity | Appetitive BehaviorUnited States
-
Yi YangNot yet recruiting
-
Mclean HospitalNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterRecruitingSchizophrenia | Schizo Affective DisorderUnited States
-
Tehran University of Medical SciencesUnknownBorderline Personality Disorder
-
Kaohsiung Veterans General Hospital.RecruitingBipolar II Disorder, Most Recent Episode Major DepressiveTaiwan
-
University of AlbertaRecruitingDepressive Disorder, Treatment-ResistantCanada