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The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury

This study has been withdrawn prior to enrollment.
(test device not approved to be used)
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01127789
First received: March 8, 2010
Last updated: December 20, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to study motor learning and recovery of patients with brain damage caused by traumatic brain injury or stroke with transcranial direct current stimulation (tDCS). It is hypothesized that anodal tDCS on the lesion side and/or cathodal tDCS on the healthy side of motor cortex could improve the recovery of motor function such as learning.


Condition Intervention Phase
Traumatic Brain Injury
Stroke
 Device: Transcranial Direct Current Stimulation
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Reaction time (millisecond) [ Time Frame: 24 hours post intervention ] [ Designated as safety issue: No ]
    Primary outcome measure is the average reaction time of 360 trials from each block -- the task is composed of 8 blocks. After intervention, 3 blocks will be re-tested for 3 times to evaluate the consolidating effect of tDCS on motor learning.


Secondary Outcome Measures:
  • Error rate (percentage) [ Time Frame: 24 hours post intervention ] [ Designated as safety issue: No ]
    Secondary outcome measure is the error rate of each block which will be re-tested for 3 times after intervention. The aim is to evaluate the motor learning effect during and after tDCS.


Enrollment: 0
Study Start Date: March 2010
Study Completion Date: November 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: non-invasive brain stimulation Device: Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation
Other Name: Chanttanooga ionto Dual Channel Stimulator

Detailed Description:

We aim to apply transcranial direct current stimulation (tDCS) to study the recovery process of motor learning on the patients with brain damage caused by traumatic brain injury or stroke. Both anodal and cathodal tDCS will be used to test whether the increase of motor cortical activity by anodal tDCS over lesional side or the decrease of brain activity by cathodal tDCS on healthy side will improve the learning skill (SRTT: serial reaction time task). The result could help to understand the mechanism of motor and cognitive recovery after brain damage, and further rationalize the application of non-invasive brain stimulation such as tDCS for patient rehabilitation.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • TBI or stroke patients
  • with partially preserved fine motor function

Exclusion Criteria:

  • with metal clips in head or device (e.g. pacemaker)
  • with active CNS drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01127789

Locations
Taiwan
Dpt. Physical Medicine and Rehabilitation, NTUH
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Wen-Shiang Chen, MD, PhD Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01127789     History of Changes
Other Study ID Numbers: 200910005R
Study First Received: March 8, 2010
Last Updated: December 20, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Stroke
Brain Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013