Intermittent Theta Burst Stimulation After Acute Stroke

Ischemic Stroke, Clinical Trial

Official title:

Theta Burst Stimulation on the Motor Cortex in Acute Stroke: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01323881
• Other study ID #: VGHIRB98-05-05
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 24, 2011
• Last updated: May 23, 2014
• Start date: May 2009

Study information

• Verified date: May 2009
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ischemic Stroke,
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Hsu YF, Huang YZ, Lin YY, Tang CW, Liao KK, Lee PL, Tsai YA, Cheng HL, Cheng H, Chern CM, Lee IH. Intermittent theta burst stimulation over ipsilesional primary motor cortex of subacute ischemic stroke patients: a pilot study. Brain Stimul. 2013 Mar;6(2): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of Action Research Arm test	We assess the changes of Action Research Arm test between before the intervention and the 60th day post-stroke.	60th day post-stroke	Yes
Secondary	The changes of upper limb function and corticospinal excitability	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	60th day post-stroke	Yes