Text Size

Transcranial Direct Current Stimulation and Motor Training for Traumatic Brain Injury Survivors (tDCS TBI)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01749735
First received: December 6, 2011
Last updated: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

The aim of this study is to compare the effect of transcranial direct current stimulation and functional upper extremity task training to functional upper extremity task task training alone. The functional upper extremity task training takes uses the Armeo Spring robotic arm to support the limb while playing functional task games on the computer.

Specific Aims:

  1. To demonstrate that tDCS combined with upper extremity functional task training in a virtual environment is more effective than functional task training in a virtual environment with sham tDCS.
  2. To compare cortico-excitatory changes following training with tDCS vs. sham stimulation, using paired- and single-pulse transcranial magnetic stimulation as a tool to measure cortical excitability.

Condition Intervention
Traumatic Brain Injury
 Device: Transcranial Direct Current Stimulation
Device: Sham Transcranial Direct Current Stimulation
Device: Armeo training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Traumatic Brain Injury Survivors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spaulding Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in Jebsen-Taylor Hand Function Test score from Baseline [ Time Frame: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post ] [ Designated as safety issue: No ]
  • Change in Box and Block Test score from Baseline [ Time Frame: Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Armeo training with continuous tDCS Device: Transcranial Direct Current Stimulation
Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Other Names:
  • Device name: Phoresor II Auto
  • Produced by: Iomed
Device: Armeo training
Upper extremity training with the use of a weight support device and virtual reality.
Other Names:
  • Device: Armeo
  • Produced by: Hocoma
Sham Comparator: Armeo training with sham tDCS Device: Sham Transcranial Direct Current Stimulation
Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
Other Names:
  • Device name: Phoresor II Auto
  • Produced by: Iomed
Device: Armeo training
Upper extremity training with the use of a weight support device and virtual reality.
Other Names:
  • Device: Armeo
  • Produced by: Hocoma

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-70 years
  • First-time moderate to severe TBI
  • Arm weakness

Exclusion Criteria:

  • History of seizures
  • Major depression
  • Agitated Behavior Scale >21
  • Cognitive Impairment that interferes with understanding instructions
  • Pregnancy
  • Implants (e.g. metal plates, shunts, pacemaker)
  • Participation in other upper extremity rehab or TBI study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749735

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spaulding Rehabilitation Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Paolo Bonato, Director, Motion Analysis Lab, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01749735     History of Changes
Other Study ID Numbers: 2009-P-000700
Study First Received: December 6, 2011
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013