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Trial record 17 of 289 for:    Fluoxetine

Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

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ClinicalTrials.gov Identifier: NCT02208466
Recruitment Status : Recruiting
First Posted : August 5, 2014
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stroke Motor Function Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS) Drug: Fluoxetine Device: Sham repetitive transcranial magnetic stimulation (rTMS) Drug: Placebo Fluoxetine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients
Study Start Date : September 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Experimental: Active rTMS/active fluoxetine
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.
Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Other Name: magnetic stimulation, Magstim

Drug: Fluoxetine
Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
Other Name: Prozac, Sarafem, Ladose, Fontex

Experimental: Sham rTMS/active fluoxetine
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.
Drug: Fluoxetine
Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
Other Name: Prozac, Sarafem, Ladose, Fontex

Device: Sham repetitive transcranial magnetic stimulation (rTMS)
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.
Other Name: Magstim, magnetic stimulation

Experimental: Sham rTMS/placebo fluoxetine
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.
Device: Sham repetitive transcranial magnetic stimulation (rTMS)
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.
Other Name: Magstim, magnetic stimulation

Drug: Placebo Fluoxetine
Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
Other Name: Prozac, Sarafem, Ladose, Fontex




Primary Outcome Measures :
  1. Changes in Motor Function [ Time Frame: Measured over 90 days ]
    We will measure motor function using behavioral tasks (ex. jebsen taylor test, purdue pegboard, range of motion) before and after stimulation sessions at three different time-points.


Secondary Outcome Measures :
  1. Changes in cortical excitability measures [ Time Frame: Measured over 90 days ]
    We will measure cortical excitability using single-pulsed transcranial magnetic stimulation (TMS) before and after stimulation at three different time-points.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic infarction within the past 2 years post event that has caused hemiparesis or hemiplegia, as self-reported and/or confirmed by medical record.
  • Older than 18 years old.
  • Upper extremity weakness defined as a score of >11 and ≤56 on the arm motor Fugl-Mayer motor scale.
  • Minimal pre-stroke disability defined as a score of <3 in the Modified Rankin Scale.
  • Subjects need to be able to follow directions and participate in 2 hours of testing with short breaks.
  • Subjects need to be able to provide informed consent.

Exclusion Criteria:

  • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instruction for motor testing
  • Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects), as self reported
  • Contraindications to single pulse TMS (will be used to measure cortical excitability) such as: history of seizures, unexplained loss of consciousness, any metal implants in the head, frequent or severe headaches or neck pain, any other electronic implanted medical devices such as pacemakers, defibrillators, or implant medication pump.
  • Patients who have taken fluoxetine in the past 5 weeks.
  • Patients taking any other SSRI at the time of enrollment or in the previous month.
  • Patients taking any other medication likely to have adverse interaction with SSRIs (all the medications the patient is taking will be carefully reviewed, as noted below in "Monitoring of important drug interactions").
  • Active depression on admission to SRH defined by a score of 24 or higher in the Hamilton Depression Rating Scale (HAM-D)
  • Concurrent medical condition likely to worsen patient's functional status in the next 6 months such as: cancer, terminal heart, kidney or liver disease, as self-reported and/or confirmed by medical record.
  • Pregnancy.

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): NCT02208466


Contacts
Contact: Felipe Fregni, MD, PhD, MPH 617-952-6156 ffregni@partners.org
Contact: Sarah Daly, BS 617-952-6153 sdaly1@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Felipe Fregni, MD PhD MPH Spaulding Rehabilitation Hospital

Responsible Party: Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02208466     History of Changes
Other Study ID Numbers: 2014P001046
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Felipe Fregni, Spaulding Rehabilitation Hospital:
repetitive transcranial magnetic stimulation
rTMS
TMS
fluoxetine

Additional relevant MeSH terms:
Fluoxetine
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors