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Effects of rTMS and tDCS on Motor Function in Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01574989
First received: February 8, 2012
Last updated: April 14, 2014
Last verified: April 2014

February 8, 2012
April 14, 2014
May 2011
May 2014   (final data collection date for primary outcome measure)
Changes in cortical excitability measures [ Time Frame: Measured for approximately 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01574989 on ClinicalTrials.gov Archive Site
Changes in motor function [ Time Frame: Measured for approximately 6 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effects of rTMS and tDCS on Motor Function in Stroke
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Stroke
  • Motor Function
  • 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 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
26
Not Provided
May 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01574989
2010-p-001461
No
Felipe Fregni, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
April 2014

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