Intermittent Theta Burst Stimulation After Acute Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT01323881
First received: March 24, 2011
Last updated: May 23, 2014
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • The changes of Action Research Arm test [ Time Frame: 60th day post-stroke ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: March 24, 2011
Last Updated: May 23, 2014
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014