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

NCT01127789 | Withdrawn Phase 1 DMC

• 1 other identifier: 200910005R
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours post intervention

Secondary Outcomes (1)

• Error rate (percentage)

  24 hours post intervention

Study Arms (1)

non-invasive brain stimulation

EXPERIMENTAL

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

Transcranial Direct Current Stimulation

Also known as: Chanttanooga ionto Dual Channel Stimulator

non-invasive brain stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• with metal clips in head or device (e.g. pacemaker)
• with active CNS drugs

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Dpt. Physical Medicine and Rehabilitation, NTUH

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Wen-Shiang Chen, MD, PhD

  Dpt. Physical Medicine and Rehabilitation, NTUH Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: May 21, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: November 1, 2012
• Last Updated: December 21, 2012

Record last verified: 2012-11

Locations

TW (1)