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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 24, 2020
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date April 24, 2020
Study Start Date  ICMJE May 2011
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of rTMS and tDCS on Motor Function in Stroke
Official Title  ICMJE Effects of Repetitive Transcranial Magnetic Stimulation and Transcranial DC Stimulation on Motor Function in Stroke Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Stroke
  • Motor Function
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Device: Transcranial Direct Current Stimulation (tDCS)
  • 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Device: Transcranial Direct Current Stimulation (tDCS)
  • 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Device: Transcranial Direct Current Stimulation (tDCS)
  • 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Device: Transcranial Direct Current Stimulation (tDCS)
  • 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.
    Interventions:
    • Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
    • Device: Transcranial Direct Current Stimulation (tDCS)
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:CD009645. doi: 10.1002/14651858.CD009645.pub4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
26
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574989
Other Study ID Numbers  ICMJE 2010-p-001461
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felipe Fregni, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP