Back to resultsThe Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
Primary Purpose
Traumatic Brain Injury, Stroke
Status
Withdrawn
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility 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
Sites / Locations
- Dpt. Physical Medicine and Rehabilitation, NTUH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
non-invasive brain stimulation
Arm Description
Outcomes
Primary Outcome Measures
Reaction time (millisecond)
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)
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.
Full Information
NCT ID
NCT01127789
First Posted
March 8, 2010
Last Updated
December 20, 2012
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01127789
Brief Title
The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
Official Title
The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Why Stopped
test device not approved to be used
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-invasive brain stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
Chanttanooga ionto Dual Channel Stimulator
Intervention Description
Transcranial Direct Current Stimulation
Primary Outcome Measure Information:
Title
Reaction time (millisecond)
Description
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.
Time Frame
24 hours post intervention
Secondary Outcome Measure Information:
Title
Error rate (percentage)
Description
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.
Time Frame
24 hours post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Shiang Chen, MD, PhD
Organizational Affiliation
Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dpt. Physical Medicine and Rehabilitation, NTUH
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived
Learn more about this trial
The Use of Transcranial Direct Current Stimulation (tDCS) to Study Implicit Motor Learning on Patients With Brain Injury
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