Transcranial Direct Current Stimulation and Motor Training for Traumatic Brain Injury Survivors

Traumatic Brain Injury Clinical Trial

— tDCS TBI  

Official title:

The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Traumatic Brain Injury Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749735
• Other study ID #: 2009-P-000700
• Status: Completed
• Phase: N/A
• First received: December 6, 2011
• Last updated: September 12, 2013
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

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.
• 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.
• Armeo training
Upper extremity training with the use of a weight support device and virtual reality.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jebsen-Taylor Hand Function Test score from Baseline		Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post	No
Primary	Change in Box and Block Test score from Baseline		Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post	No

External Links

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