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Effects of rTMS and tDCS on Motor Function in Stroke

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ClinicalTrials.gov Identifier: NCT01574989
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Motor Function Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Device: Transcranial Direct Current Stimulation (tDCS) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
Study Start Date : May 2011
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 1x1 low-intensity direct current stimulator; Soterix Medical


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574989


Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Felipe Fregni, Associate Professor, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01574989     History of Changes
Other Study ID Numbers: 2010-p-001461
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2016

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
direct current stimulation
magnetic stimulation
transcranial stimulation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases