Effects of rTMS and tDCS on Motor Function in Stroke

Completed

Phase N/A Results N/A

Trial Description

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

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Active low-frequency rTMS/sham tDCS
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Active high-frequency rTMS/sham tDCS
    Description: 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.
    ARM 3: Kind: Experimental
    Label: Sham rTMS/active anodal tDCS
    Description: 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.
    ARM 4: Kind: Experimental
    Label: Sham rTMS/active cathodal tDCS
    Description: 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.
    ARM 5: Kind: Experimental
    Label: Sham rTMS/Sham tDCS
    Description: 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.
  • Transcranial direct current stimulation (tDCS) Device
    Other Names: tDCS; Low intensity transcranial DC stimulator; Soterix 1x1
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Active low-frequency rTMS/sham tDCS
    Description: 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.
    ARM 2: Kind: Experimental
    Label: Active high-frequency rTMS/sham tDCS
    Description: 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.
    ARM 3: Kind: Experimental
    Label: Sham rTMS/active anodal tDCS
    Description: 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.
    ARM 4: Kind: Experimental
    Label: Sham rTMS/active cathodal tDCS
    Description: 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.
    ARM 5: Kind: Experimental
    Label: Sham rTMS/Sham tDCS
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Basic Science
  • Endpoint: Safety/Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in cortical excitability measures Measured for approximately 6 weeks No
Secondary Changes in motor function Measured for approximately 6 weeks No

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