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

NCT01749735 | Terminated Results

• 1 other identifier: 2009-P-000700
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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 training alone. The functional upper extremity task training uses the Armeo Spring robotic arm to support the limb while playing functional task games on a computer. Specific Aims:

1. 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. 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Change in Jebsen-Taylor Hand Function Test Score From Baseline

  The Jebsen-Taylor Hand Function Test is a functional test consisting of 7 subtests. Each subtest requires that the subject performs a motor task (e.g. using one hand to pick up a small object positioned on a table in front of the subject). The test score is derived by measuring (using a stopwatch) the time in sec that the subject needs to complete the task. Individuals with no motor impairments typically need between 30 and 60 sec to complete the 7 subtests of the Jebsen-Taylor Hand Function Test.

  Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post

• Change in Box and Block Test Score From Baseline

  The Box and Block Test is a functional test. Subjects are instructed to move small blocks from one box to a second box. The test measures the number of blocks that subjects can move during a period of 60 sec. The measurement unit for this task is the "number of blocks". Subjects with no motor impairments would typically move about 60 to 80 blocks in a period of 60 sec.

  Baseline, Day 5 (midpoint), Day 10 (endpoint), 1 wk post, 2 wks post, 4 wks post

Study Arms (2)

Armeo training with continuous tDCS

EXPERIMENTAL

Subjects will receive 10 sessions of transcranial Direct Current Stimulation (tDCS)/Armeo training over 2 weeks. Training sessions will last for 40 minutes and will focus on repetitive tasks using the Armeo device that. To deliver the stimulation, the anode will be placed over the primary motor cortex (M1) of the affected hemisphere, while the cathode will be placed over the unaffected M1 area. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2). Continuous stimulation will be delivered at an intensity of 1mA while the subject undergoes the 40-minute Armeo motor training sessions.

Device: Transcranial Direct Current Stimulation; Device: Armeo training

Armeo training with sham tDCS

SHAM COMPARATOR

Subjects will receive the same number of 40-minute training sessions (i.e. 10 sessions) as the subjects in the experimental group. Training will take place over a period of two weeks as per the experimental group. Also, electrodes will be positioned on the scalp as per the experimental group. However, for sham transcranial Direct Current Stimulation (tDCS), the current will be delivered for only 30 seconds. The current intensity will be gradually increased and decreased to diminish its perception.

Device: Sham Transcranial Direct Current Stimulation; Device: Armeo training

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: Device name: Phoresor II Auto, Produced by: Iomed

Armeo training with continuous tDCS

Sham Transcranial Direct Current Stimulation DEVICE

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.

Also known as: Device name: Phoresor II Auto, Produced by: Iomed

Armeo training with sham tDCS

Armeo training DEVICE

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

Also known as: Device: Armeo, Produced by: Hocoma

Armeo training with continuous tDCS; Armeo training with sham tDCS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Related Links

• short description of the study
• short description of the study

MeSH Terms

Conditions

Brain Injuries, Traumatic

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

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Patient 1 did not finish study (stopped in follow up week 2). Patient 2 missed 2 training sessions. Both patients received the intervention (tDCS group) according to the confidential patient log. There was no control group available for comparison.

Results Point of Contact

• Title: Dr. Paolo Bonato
• Organization: Spaulding Rehabilitation Hospital

pbonato@partners.org

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Lab

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 17, 2012
• Study Start: July 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 4, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)