Effects of rTMS and tDCS on Motor Function in Stroke

April 23, 2020 updated by: Felipe Fregni, Spaulding Rehabilitation Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

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

Exclusion criteria:

  1. History of Major depression, as defined by Beck Depression scale 30;
  2. Any substantial decrease in alertness, language comprehension, or attention that might interfere with understanding instructions for motor testing;

  3. Contraindications to TMS

    • history of seizures
    • unexplained loss of consciousness
    • metal in the head
    • frequent or severe headaches or neck pain
    • implanted brain medical devices.

  4. Contraindications to tDCS

    • metal in the head
    • implanted brain medical devices
  5. Advanced liver, kidney, cardiac, or pulmonary disease;
  6. A terminal medical diagnosis consistent with survival < 1 year;
  7. Coexistent major neurological or psychiatric disease (to decrease number of confounders);
  8. A history of significant alcohol or drug abuse in the prior 6 months;
  9. Subjects may not be actively enrolled in a separate intervention study targeting stroke recovery and any other clinical trials;
  10. Subjects with global aphasia and deficits of comprehension
  11. 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.
  12. Use of neuropsychotropic medications [healthy subjects only]

Additional inclusion criteria for stroke subjects:

  1. First-time clinical ischemic or hemorrhagic cerebrovascular events - evidenced by a radiological (or physician's) report
  2. Weakness, defined as score of less than 55 (out of 66) on arm motor Fugl-Meyer (FM) scale
  3. Stroke onset >6 months prior to study enrollment .

Additional exclusion criteria for stroke subjects:

  1. Subjects may not have already received TMS and/or tDCS stimulation for stroke;
  2. History of epilepsy before stroke or episodes of seizures within the last six months;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Active low-frequency rTMS/sham 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • magnetic stimulation; Magstim
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • 1x1 low-intensity direct current stimulator; Soterix Medical
EXPERIMENTAL: Active high-frequency rTMS/sham 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • magnetic stimulation; Magstim
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • 1x1 low-intensity direct current stimulator; Soterix Medical
EXPERIMENTAL: Sham rTMS/active anodal 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • magnetic stimulation; Magstim
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • 1x1 low-intensity direct current stimulator; Soterix Medical
EXPERIMENTAL: Sham rTMS/active cathodal 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • magnetic stimulation; Magstim
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • 1x1 low-intensity direct current stimulator; Soterix Medical
SHAM_COMPARATOR: Sham rTMS/Sham 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.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Names:
  • magnetic stimulation; Magstim
Device: Transcranial Direct Current Stimulation (tDCS)
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.
Other Names:
  • 1x1 low-intensity direct current stimulator; Soterix Medical

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Measured for approximately 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in motor function
Time Frame: Measured for approximately 6 weeks
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 for approximately 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2010-p-001461

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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