Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
NCT Number: NCT02208466
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Charlestown, Massachusetts, 02129, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
Other names: Prozac, Sarafem, Ladose, Fontex
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
Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
Other names: Prozac, Sarafem, Ladose, Fontex
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).
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).
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).
Spaulding Rehabilitation Hospital
Other
Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients
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