Traumatic Brain InjuryNCT01749735

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

A study testing Transcranial Direct Current Stimulation and Armeo training in people with Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Transcranial Direct Current Stimulation and Armeo training
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Jul 2011to Sep 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129

Other trials in United States

About this study

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

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:

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.
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.

Read the detailed description

This is a randomized, double-blinded, sham-controlled study comparing sham and continuous tDCS combined with repetitive upper extremity functional task training in a virtual environment. Subjects will be randomized to 1 of 2 groups: Armeo training with continuous tDCS, or sham tDCS through a randomization stratification approach. Subjects will be grouped into strata defined by the degree of weakness, and then randomized separately within each stratum according to a block randomization of 6 to receive Armeo training-continuous tDCS, or Armeo training-sham stimulation. Each subject will receive 10 training sessions over 2 weeks. Training sessions will last for 40 minutes and will focus on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand. We will use a variety of virtual tasks (computer games) in the training. Examples of the virtual tasks include 1) picking up objects from shelves placed against different walls of a room and placing them in a bin in the center foreground of the screen, 2) picking up eggs from a basket and cracking them over a frying pan, 3) picking up objects at a virtual supermarket and placing them in the shopping cart, 4) cleaning a stove top. In between training sessions, subjects will be encouraged to use the affected arm in daily activities. This will be assessed with the Motor Activity Log.

tDCS will be delivered by positioning the anode over the primary motor cortex (M1) of the affected hemisphere, while the cathode will be placed over the unaffected M1 area. The electrode localization method will be according to the International 10-20 Electrode Placement System for placement of EEG electrodes. This method has been validated with a frameless stereotactic system. Direct current will be transferred by a saline-soaked pair of surface sponge electrode (35cm2) and delivered by a battery-driven, constant current stimulator with a maximum output of 10mA. An intensity of 1mA will be used in this study (current density of 0.04 μA/cm2). Continuous stimulation will be delivered at an intensity of 1mA while the subject undergoes the 40-minute Armeo motor training sessions. For sham stimulation, the same parameters will be employed. However, the current will be applied for 30 seconds only. Current intensity will be gradually increased and decreased to diminish its perception.

Outcome measures will be performed prior to treatment initiation, at day 5, 10, and at follow-up week 1, 2 and 4 after the end of treatment. A rater blinded to the treatment will assess the effects of the intervention using the Jebsen-Taylor Hand Function Test and Box and Block Test.

Conditions: Traumatic Brain Injury
Being tested: Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation, Armeo training
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current StimulationDevice
Also called Device name: Phoresor II Auto, Produced by: Iomed
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 StimulationDevice
Also called Device name: Phoresor II Auto, Produced by: Iomed
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 trainingDevice
Also called Device: Armeo, Produced by: Hocoma
Upper extremity training with the use of a weight support device and virtual reality.

Study groups in NCT01749735
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation; Device: Armeo training

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Sep 2013

First posted17 Dec 2012 (estimated)
Study startJul 2011
Primary completionSep 2013
Study completionSep 2013

Why it stopped: The study was terminated because of lack of funding.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01749735
Sponsor's protocol ID: 2009-P-000700
Status last verified: Mar 2017
First submitted: 6 Dec 2011
Last updated: 4 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Transcranial Direct Current Stimulation Combined With Functional Task Training on Motor Recovery in Traumatic Brain Injury Survivors
ClinicalTrials.gov ID: NCT01749735
Acronym / sponsor ID: 2009-P-000700
Conditions: Traumatic Brain Injury
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was terminated because of lack of funding.
Enrolment: 2 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: Jul 2011
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 17 Dec 2012 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Specific Aims:

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.
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Armeo training with continuous tDCS	Experimental	Device: Transcranial Direct Current Stimulation, Device: Armeo trainingSubjects 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.
Armeo training with sham tDCS	Sham comparator	Device: Sham Transcranial Direct Current Stimulation, Device: Armeo trainingSubjects 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

History of seizures
Major depression
Agitated Behavior Scale >21
Cognitive Impairment that interferes with understanding instructions
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial Direct Current StimulationAlso: Device name: Phoresor II Auto, Produced by: IomedContinuous 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.	Device	Armeo training with continuous tDCS
Sham Transcranial Direct Current StimulationAlso: Device name: Phoresor II Auto, Produced by: IomedSham 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.	Device	Armeo training with sham tDCS
Armeo trainingAlso: Device: Armeo, Produced by: HocomaUpper extremity training with the use of a weight support device and virtual reality.	Device	Armeo training with continuous tDCS, Armeo training with sham tDCS

Primary outcome

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
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.
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
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.

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Armeo Training With Continuous tDCS	2	1
Armeo Training With Sham tDCS	0	0

Primary outcome: 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. Mean (Standard Deviation). Unit: seconds

Measure	Armeo Training With Continuous tDCS n = 2	Armeo Training With Sham tDCS n = 0
Day 5	-71.9 (67.9)	–
Day 10	-79.0 (66.6)	–
1 week post	-20.1 (151.2)	–
2 weeks post	-17.4 (NA)	–
4 weeks post	-26.9 (NA)	–

Primary outcome: 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. Mean (Standard Deviation). Unit: number of blocks

Measure	Armeo Training With Continuous tDCS n = 2	Armeo Training With Sham tDCS n = 0
Day 5	2.5 (3.5)	–
Day 10	3.5 (3.5)	–
1 week post	3 (4.2)	–
2 weeks post	1 (0)	–
4 weeks post	6 (0)	–

Adverse events

Time frame: No adverse events were observed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Armeo Training With Continuous tDCS	0 of 2 (0%)	1 of 2 (50%)	Not reported
Armeo Training With Sham tDCS	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
short description of the studyLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Paolo Bonato, PhD principal investigator

Spaulding Rehabilitation Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation and Armeo training in people with Traumatic Brain Injury, run by Spaulding Rehabilitation Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01749735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.