StroketdcsNCT01143649

Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient

A study testing transcranial direct current stimulation (tDCS), constraint induced movement therapy (CIMT) and transcranial alternating current stimulation (tACS) in people with Stroke and Healthy, run by Spaulding Rehabilitation Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Stroke, Healthy
What is being tested?: transcranial direct current stimulation (tDCS), constraint induced movement therapy (CIMT) and transcranial alternating current stimulation (tACS)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Jan 2016
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 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

All subjects must be between the ages of 18-90 and must not be pregnant.
Additional Entry criteria for Stroke subject enrollment:
First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;
Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
Stroke onset >6 months prior to study enrollment.

Who cannot join

Significant pre-stroke disability;
Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;
Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);
Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants
history of seizures

Show all 23Show fewer

unexplained loss of consciousness
metal in the head
frequent or severe headaches or neck pain
implanted brain medical devices.
Contraindications to tDCS
metal in the head
implanted brain medical devices
Advanced liver, kidney, cardiac, or pulmonary disease;
A terminal medical diagnosis consistent with survival < 1 year;
Coexistent major neurological or psychiatric disease as to decrease number of confounders;
A history of significant alcohol or drug abuse in the prior 6 months;
Use of carbamazepine and amitriptyline;
Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and
Subjects may not have already received constraint induced motor therapy and/or tDCS treatment for stroke;
History of epilepsy before stroke (or episodes of seizures within the last six months).
Subjects with global aphasia and deficits of comprehension
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.

Read the detailed description

In this 3 experiments study we will evaluate the effect of tDCS and constraint induced movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control population - exp 2). Finally we will investigate the effect of tACS - transcranial alternating current stimulation - as an alternative to tDCS, on motor function in healthy subjects (exp 3). The two experiments on tDCS are parallels (exp 1 \& 2), while the experiment on tACS uses a crossover design (exp 3).

For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally, for the third experiment using tACS, our primary outcome is cortical oscillation, as measured by EEG - electroencephalogram.

Conditions: Stroke, Healthy
Being tested: transcranial direct current stimulation (tDCS), constraint induced movement therapy (CIMT), transcranial alternating current stimulation (tACS)
Keywords: Stroke, Transcranial direct current stimulation, Motor function
Medical subject headings: Stroke

What participants receive

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

transcranial direct current stimulation (tDCS)Device
Subjects will be stimulated at 1 mA for 40 minutes.
constraint induced movement therapy (CIMT)Procedure or surgery
transcranial alternating current stimulation (tACS)Device
Subjects will be stimulated at 15Hz for 20 minutes.

Study groups in NCT01143649
Study group	Role	What they receive
active tDCS + CIMT - stroke patients	Experimental	Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday). Receives: Device: transcranial direct current stimulation (tDCS); Procedure: constraint induced movement therapy (CIMT)
active tDCS + CIMT - Healthy	Experimental	Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT) Receives: Device: transcranial direct current stimulation (tDCS); Procedure: constraint induced movement therapy (CIMT)
tACS - Healthy Subjects	Experimental	The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized). Receives: Device: transcranial alternating current stimulation (tACS)
sham tDCS + CIMT - stroke patients	Sham comparator	Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday). For the sham session, tDCS is turned off after 30seconds. Receives: Device: transcranial direct current stimulation (tDCS); Procedure: constraint induced movement therapy (CIMT)
sham tDCS + CIMT - Healthy	Sham comparator	Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment. Receives: Device: transcranial direct current stimulation (tDCS); Procedure: constraint induced movement therapy (CIMT)
sham tACS - Healthy Subjects	Sham comparator	The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order. Receives: Device: transcranial alternating current stimulation (tACS)

What is being measured

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

Jebsen Taylor Hand Function Test
Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.
Measured: 2 weeks
Cortical Excitability
Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham).
The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison.
Measured: 1 hour
Cortical Oscillations - EEG
Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.
Measured: 15 minutes

Timeline

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

Apr 2010Jan 2016

First posted14 Jun 2010 (estimated)
Study startApr 2010
Primary completionApr 2011
Study completionJan 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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, Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01143649
Sponsor's protocol ID: 2009p001808
Acronym: tdcs
Status last verified: Apr 2020
First submitted: 20 Apr 2010
Last updated: 24 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 33175411

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 Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
ClinicalTrials.gov ID: NCT01143649
Acronym / sponsor ID: tdcs / 2009p001808
Conditions: Stroke, Healthy
Keywords: Stroke, Transcranial direct current stimulation, Motor function
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: Apr 2010 (actual)
Primary completion: Apr 2011 (actual)
Study completion: Jan 2016 (actual)
First posted: 14 Jun 2010 (estimated)
Results: Posted 6 Mar 2017

Clinical summary

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

The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
active tDCS + CIMT - stroke patients	Experimental	Device: transcranial direct current stimulation (tDCS), Procedure: constraint induced movement therapy (CIMT)Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday).
active tDCS + CIMT - Healthy	Experimental	Device: transcranial direct current stimulation (tDCS), Procedure: constraint induced movement therapy (CIMT)Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT)
tACS - Healthy Subjects	Experimental	Device: transcranial alternating current stimulation (tACS)The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).
sham tDCS + CIMT - stroke patients	Sham comparator	Device: transcranial direct current stimulation (tDCS), Procedure: constraint induced movement therapy (CIMT)Participants will receive 5 sessions of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT - 10 consecutive sessions Monday- Friday). For the sham session, tDCS is turned off after 30seconds.
sham tDCS + CIMT - Healthy	Sham comparator	Device: transcranial direct current stimulation (tDCS), Procedure: constraint induced movement therapy (CIMT)Participants will receive one session of tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.
sham tACS - Healthy Subjects	Sham comparator	Device: transcranial alternating current stimulation (tACS)The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

All subjects must be between the ages of 18-90 and must not be pregnant.
First-time clinical ischemic or hemorrhagic cerebrovascular accident - evidenced by a radiological (or physician's) report;
Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
Stroke onset >6 months prior to study enrollment.

Key exclusion criteria (23 listed)

Significant pre-stroke disability;
Major depression, as defined by Hamilton Depression (HAM-D) scale grater then or equal 17 if needed (history of depression before the stroke);
Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing;
Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects);
Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants

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 stimulation (tDCS)Subjects will be stimulated at 1 mA for 40 minutes.	Device	active tDCS + CIMT - Healthy, active tDCS + CIMT - stroke patients, sham tDCS + CIMT - Healthy, sham tDCS + CIMT - stroke patients
constraint induced movement therapy (CIMT)	Procedure or surgery	active tDCS + CIMT - Healthy, active tDCS + CIMT - stroke patients, sham tDCS + CIMT - Healthy, sham tDCS + CIMT - stroke patients
transcranial alternating current stimulation (tACS)Subjects will be stimulated at 15Hz for 20 minutes.	Device	sham tACS - Healthy Subjects, tACS - Healthy Subjects

Primary outcome

Jebsen Taylor Hand Function Test
Time frame: 2 weeks
Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-cronstrained hand for the assessments. The sum of the different tasks was used for the analysis.
Cortical Excitability
Time frame: 1 hour
Motor evoked potential (MEP) Using Transcranial Magnetic Stimulation (TMS), MEP were recorded before and after tDCS (both active and sham). The percentage of change in MEP (post versus pre intervention) between the two groups (active and sham) were used for the comparison.
Cortical Oscillations - EEG
Time frame: 15 minutes
Recording took place in a dim-lighted room set up with acoustic and electric isolation. EEG was acquired from 64-channels HydroCel Geodesic Sensor Net (Electrical Geodesic Inc., Eugene, OH) and recorded using Net Station running on a MacIntosh G4 computer. Alpha power were used as the main outcome measure. The difference values (e.g., post minus pre tACS) were used for the analysis. The alpha frequency is a brain oscillation that takes place especially when subjects are in a relaxed state, especially eyes closed. In the motor cortex, a decrease in alpha power has been seen during motor performance. Therefore, it could be speculated that a decrease in power in this study would indicate more engagement in motor cortex during the motor performance.

Results and safety

Results posted to the registry on 6 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
tDCS + CIMT - Stroke	7	7
Sham tDCS + CIMT - Stroke	7	7
Healthy Participants: Active tDCS + Motor Training	10	10
Healthy Participants: Sham tDCS + Motor Training	10	10
Healthy Participants - Active tACS, Then Sham	5	4
Healthy Participants - Sham tACS, Then Active	5	3

Primary outcome: Jebsen Taylor Hand Function Test

Time frame: 2 weeks. Mean (Standard Error). Unit: seconds

Measure	tDCS + CIMT n = 7	Sham tDCS + CIMT n = 7
Value	68 (34)	80 (42)

Population analysed: The Jebsen Taylor Hand Function Test was only performed in the stroke study (Experiment 1).

Primary outcome: Cortical Excitability

Time frame: 1 hour. Mean (Standard Deviation). Unit: percent change

Measure	Healthy Participants: Active tDCS + Motor Training n = 20	Healthy Participants: Sham tDCS + Motor Training n = 20
Value	19.8 (21.4)	0.8 (8.3)

Population analysed: The cortical excitability measurement (MEP) was performed in healthy participants involved in the tDCS+CIMT study (Experiment 2).

Primary outcome: Cortical Oscillations - EEG

Time frame: 15 minutes. Mean (Standard Deviation). Unit: microVolt^2

Measure	Healthy Participants - Active tACS n = 7	Healthy Participants - Sham tACS n = 7
Value	-0.03 (0.24)	0.07 (0.16)

Population analysed: The brain oscillations measurements were only performed in the tACS study (Experiment 3).

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS + CIMT - Stroke	0 of 7 (0%)	0 of 7 (0%)	Not reported
Sham tDCS + CIMT - Stroke	0 of 7 (0%)	0 of 7 (0%)	Not reported
Active tDCS + CIMT - Healthy	0 of 10 (0%)	0 of 10 (0%)	Not reported
Sham tDCS + CIMT - Healthy	0 of 10 (0%)	0 of 10 (0%)	Not reported
Active tACS - Healthy	0 of 10 (0%)	0 of 10 (0%)	Not reported
Sham tACS - Healthy	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33175411Elsner 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.

Related trials for Stroke

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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.

Felipe Fregni, 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?

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 5 inclusion and 23 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: finished, as of the sponsor's last update on 24 Apr 2020. 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 6 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?

Jebsen Taylor Hand Function Test (time frame: 2 weeks). The study lists 3 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 NCT01143649, which also lists 1 linked publication.

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 24 Apr 2020.