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Completed

NCT Number: NCT02208466

Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active repetitive transcranial magnetic stimulation (rTMS)

Device

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 names: magnetic stimulation, Magstim

Fluoxetine

Drug

Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.

Other names: Prozac, Sarafem, Ladose, Fontex

SHAM repetitive transcranial magnetic stimulation (rTMS)

Device

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 names: Magstim, magnetic stimulation

Placebo Fluoxetine

Drug

Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.

Other names: Prozac, Sarafem, Ladose, Fontex

Primary outcomes

  1. Changes in Motor Function (Jebsen-Taylor Task)

    Time frame: baseline and 90 days

    Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-constrained hand for the assessments. The sum of the different tasks was used for the analysis.

    Calculation details: value at 9 months minus value at baseline, change in seconds (adjusted mean difference).

  2. Changes in Fugl-Meyer Assessment (FMA) Scale

    Time frame: baseline and 90 days

    The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. We used the upper limb motor function subscale: minimum values= 0 ; maximum values= 66. Higher scores mean a better outcome. Changes from baseline to 90 days (value at 90 days minus value at baseline).

Secondary outcomes

  1. Changes in Cortical Excitability Measures

    Time frame: Baseline and 90 days

    We will measure cortical excitability using single-pulsed transcranial magnetic stimulation (TMS) before and after stimulation at three different time-points. Changes from baseline to 90 days (value at 90 days minus value at baseline).

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 5, 2014
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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