StrokeNCT01574989

Effects of rTMS and tDCS on Motor Function in Stroke

A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS) in people with Stroke and Motor Function, 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

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Stroke, Motor Function
What is being tested?: Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS)
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: May 2011to Nov 2014
Phase: Interventional
Are there results?: None posted in the registry

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.

Who cannot join

History of Major depression, as defined by Beck Depression scale 30;
Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;
Contraindications to TMS
history of seizures
unexplained loss of consciousness
metal in the head

Show all 26Show fewer

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 (to decrease number of confounders);
A history of significant alcohol or drug abuse in the prior 6 months;
Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;
Subjects with global aphasia and deficits of comprehension
Pregnancy. Female subjects of child bearing potential will be asked to take a pregnancy test. If the pregnancy test is positive, the subject may not enroll in the study.
Use of neuropsychotropic medications [healthy subjects only]
Additional inclusion criteria for stroke subjects:
First-time clinical ischemic or hemorrhagic cerebrovascular events - 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 .
Additional exclusion criteria for stroke subjects:
Subjects may not have already received TMS and/or tDCS stimulation for stroke;
History of epilepsy before stroke or episodes of seizures within the last six months;

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 Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients

In this study the investigators aim to investigate the effects of two different types of non-invasive brain stimulation techniques -- repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) on motor function in stroke. This is a cross-over study where subjects will receive 5 sessions of stimulation (each separated by 1 week) -- with either active tDCS and sham rTMS, sham tDCS and active rTMS or both sham tDCS and rTMS.

Conditions: Stroke, Motor Function
Being tested: Repetitive Transcranial Magnetic Stimulation (rTMS), Transcranial Direct Current Stimulation (tDCS)
Keywords: direct current stimulation, magnetic stimulation, transcranial stimulation
Medical subject headings: Stroke

What participants receive

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

Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Also called magnetic stimulation; Magstim
Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.
Transcranial Direct Current Stimulation (tDCS)Device
Also called 1x1 low-intensity direct current stimulator; Soterix Medical
Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.

Study groups in NCT01574989
Study group	Role	What they receive
Active low-frequency rTMS/sham tDCS	Experimental	Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, low-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)
Active high-frequency rTMS/sham tDCS	Experimental	Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, high-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)
Sham rTMS/active anodal tDCS	Experimental	Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, anodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)
Sham rTMS/active cathodal tDCS	Experimental	Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, cathodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)
Sham rTMS/Sham tDCS	Sham comparator	Subjects will have both the rTMS and tDCS on their scalp during the session, and both interventions will be sham. They will undergo only one session of this condition, and it will last 20 minutes. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Transcranial Direct Current Stimulation (tDCS)

What is being measured

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

Changes in cortical excitability measures
We will measure cortical excitability using single- and paired-pulse transcranial magnetic stimulation (TMS) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS.
Measured: Measured for approximately 6 weeks

Secondary outcomes (1)

Changes in motor function
We will measure motor function using behavioral tasks (ex. purdue pegboard, jebsen taylor test, range of motion) both before and after the stimulation sessions. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS.
Measured: Measured for approximately 6 weeks

Timeline

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

May 2011Nov 2014

First posted10 Apr 2012 (estimated)
Study startMay 2011
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01574989
Sponsor's protocol ID: 2010-p-001461
Status last verified: Apr 2020
First submitted: 8 Feb 2012
Last updated: 24 Apr 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
ClinicalTrials.gov ID: NCT01574989
Acronym / sponsor ID: 2010-p-001461
Conditions: Stroke, Motor Function
Keywords: direct current stimulation, magnetic stimulation, transcranial stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Spaulding Rehabilitation HospitalUniversity, hospital or other
Study start: May 2011
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 10 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Active low-frequency rTMS/sham tDCS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS)Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, low-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.
Active high-frequency rTMS/sham tDCS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS)Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the rTMS will be active, high-frequency, and the tDCS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.
Sham rTMS/active anodal tDCS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS)Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, anodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.
Sham rTMS/active cathodal tDCS	Experimental	Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS)Subjects will have both the rTMS and tDCS on their scalp during the session, however only one will be active. For this arm, the tDCS will be active, cathodal, and the TMS will be sham. They will undergo only one session of this condition, and it will last 20 minutes.
Sham rTMS/Sham tDCS	Sham comparator	Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Device: Transcranial Direct Current Stimulation (tDCS)Subjects will have both the rTMS and tDCS on their scalp during the session, and both interventions will be sham. They will undergo only one session of this condition, and it will last 20 minutes.

Who may qualify

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

Key inclusion criteria (1 listed)

All subjects must be between the ages of 18-90.

Key exclusion criteria (26 listed)

History of Major depression, as defined by Beck Depression scale 30;
Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;
Contraindications to TMS
Contraindications to tDCS
Advanced liver, kidney, cardiac, or pulmonary disease;

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
Repetitive Transcranial Magnetic Stimulation (rTMS)Also: magnetic stimulation; MagstimSubjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.	Device	Active high-frequency rTMS/sham tDCS, Active low-frequency rTMS/sham tDCS, Sham rTMS/Sham tDCS, Sham rTMS/active anodal tDCS, Sham rTMS/active cathodal tDCS
Transcranial Direct Current Stimulation (tDCS)Also: 1x1 low-intensity direct current stimulator; Soterix MedicalSubjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.	Device	Active high-frequency rTMS/sham tDCS, Active low-frequency rTMS/sham tDCS, Sham rTMS/Sham tDCS, Sham rTMS/active anodal tDCS, Sham rTMS/active cathodal tDCS

Primary outcome

Changes in cortical excitability measures
Time frame: Measured for approximately 6 weeks
We will measure cortical excitability using single- and paired-pulse transcranial magnetic stimulation (TMS) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS/rTMS.

1 secondary outcome

Changes in motor function
Time frame: Measured for approximately 6 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
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

Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
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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, MD PHD MPH 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 1 inclusion and 26 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Changes in cortical excitability measures (time frame: Measured for approximately 6 weeks). 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 NCT01574989, 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.