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Intermittent Theta Burst Stimulation After Acute Stroke

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323881
First Posted: March 28, 2011
Last Update Posted: May 26, 2014
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.
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan
  Purpose
This pilot sham-controlled study aims to determine the safety and efficacy of repetitive transcranial magnetic stimulation given as a facilitatory intermittent theta burst stimulation (iTBS1200, 1200 stimuli/session) paradigm to enhance motor recovery in subacute stroke patients.

Condition Intervention Phase
Ischemic Stroke, Device: Intermittent theta burst stimulation Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Theta Burst Stimulation on the Motor Cortex in Acute Stroke: a Randomized Controlled Trial

Further study details as provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • The changes of Action Research Arm test [ Time Frame: 60th day post-stroke ]
    We assess the changes of Action Research Arm test between before the intervention and the 60th day post-stroke.


Secondary Outcome Measures:
  • The changes of upper limb function and corticospinal excitability [ Time Frame: 60th day post-stroke ]
    We assess the changes of Fugl-Meyer test (FMT), active motor threshold and motor evoked potentials (MEPs) of paretic ECR between before the intervention and 60th day post-stroke


Enrollment: 20
Study Start Date: May 2009
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intermittent theta burst stimulation Device: Intermittent theta burst stimulation
Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.
Placebo Comparator: sham stimulation

Detailed Description:
The patients with first-ever, MRI-confirmed monohemispheric ischemic stroke in the middle cerebral artery territory, and NIH Stroke Scale motor arm score 1-2 with recordable active motor thresholds (aMT) of the extensor carpi radialis (ECR) between 2-4 weeks after the stroke onset, are randomized into two groups to receive either iTBS1200 or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks. All have standardized medical and intensive rehabilitation treatments. The outcome measures included Action Research Arm test (ARAT), Fugl-Meyer test (FMT), aMT and motor evoked potentials (MEPs) of ECR.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with first-ever, subacute (between 2-4 weeks post-stroke), monohemispheric ischemic stroke within the middle cerebral artery (MCA) territory, and mild to moderate hand paresis (NIHSS motor arm score 1-2) are enrolled.

Exclusion Criteria:

  • age over 75, severe hand paresis without detectable active motor threshold (aMT) of the extensor carpi radialis (ECR), seizure history (clinical or EEG abnormalities), psychosis, aphasia, apraxia, concomitant neurological diseases or severe systemic diseases (e.g. sepsis, advanced malignancy, hepatic or renal failure.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01323881


Locations
Taiwan
Taipei Veterans General Hospital
Taipei city, Taiwan, 112
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
Principal Investigator: I-Hui Lee, MD PhD Department of Neurology, Taipei Veterans General Hospital, Taipei, Taiwan
  More Information

Publications:
Responsible Party: vghtpe user, I-Hui Lee, MD PhD, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT01323881     History of Changes
Other Study ID Numbers: VGHIRB98-05-05
First Submitted: March 24, 2011
First Posted: March 28, 2011
Last Update Posted: May 26, 2014
Last Verified: May 2009

Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
theta burst stimulation, stroke, motor, plasticity

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases