Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

Recruiting

Phase 2 Results N/A

Trial Description

In this study investigator's aim to assess the effect of a type of non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in conjunction with fluoxetine on motor recovery after stroke.

Conditions

Interventions

  • Fluoxetine (ProzacĀ®)Drug
    Other Names: Patients receiving fluoxetine
    Intervention Desc: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
    ARM 1: Kind: Experimental
    Label: Active rTMS/active fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.
    ARM 2: Kind: Experimental
    Label: Sham rTMS/active fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.
  • Active Repetitive Transcranial Magnetic Stimulation (rTMS) Device
    Other Names: magnetic stimulation, Magstim
    Intervention Desc: Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.
    ARM 1: Kind: Experimental
    Label: Active rTMS/active fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.
  • Sham repetitive transcranial magnetic stimulation (rTMS) Device
    Other Names: Magstim, magnetic stimulation
    Intervention Desc: Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.
    ARM 1: Kind: Experimental
    Label: Sham rTMS/active fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.
    ARM 2: Kind: Experimental
    Label: Sham rTMS/placebo fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.
  • Placebo Fluoxetine Drug
    Other Names: Prozac, Sarafem, Ladose, Fontex
    Intervention Desc: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    ARM 1: Kind: Experimental
    Label: Sham rTMS/placebo fluoxetine
    Description: Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Changes in Motor Function Measured over 90 days No
Secondary Changes in cortical excitability measures Measured over 90 days No

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