Fregni 2014.

Trial name or title	Effects rTMS combined with fluoxetine on motor recovery in stroke patients
Methods	Study type: interventional (clinical trial) Estimated enrolment: 45 participants Allocation: randomised Intervention model: parallel assignment Masking: triple (participant, investigator, outcomes assessor) Primary purpose: treatment
Participants	Country: USA Setting: inpatient Inclusion criteria: Age > 18 years Ischaemic infarction within the past 2 years and resultant impairment Upper extremity weakness defined as a score of > 11 and ≤ 56 on the arm motor FMMS Score of < 3 in the mRSe Able to follow directions and participate in 2 hours of testing with short breaks Consent Exclusion criteria: Mental impairment that may interfere with understanding instruction for motor testing Excessive pain in any joint of the paretic extremity Contraindications to single pulse TMS Fluoxetine use in the past 5 weeks SSRI use at the time of enrolment or in the previous month Use of other medication likely to have adverse interaction with SSRIs Score of 24 or higher in the HAM‐D Concurrent medical condition likely to worsen patient's functional status in the next 6 months Pregnancy
Interventions	Experimental 1: active rTMS/active fluoxetine 10 daily 20‐minute sessions over 15 days of active low‐frequency rTMS, followed by 8 weekly 20‐minute sessions of active low‐frequency rTMS + active fluoxetine (20 mg) taken orally consecutively for 90 days Comparator 1: sham rTMS/active fluoxetine 10 daily 20‐minute sessions over 15 days of sham low‐frequency rTMS, followed by 8 weekly sessions of sham low‐frequency 20‐minute rTMS sessions + active fluoxetine (20 mg) taken orally consecutively for 90 days Comparator 2: sham rTMS/placebo fluoxetine 10 daily 20‐minute sessions over 15 days of sham low‐frequency rTMS. This will be followed by 8 weekly sessions of sham low‐frequency 20‐minute rTMS sessions + placebo fluoxetine (sugar pills) taken orally consecutively for 90 days
Outcomes	Primary outcome over 90‐day period Changes in Motor Function (JTT, Purdue Pegboard, range of motion) Secondary outcome over 90‐day period Changes in cortical excitability
Starting date	5 August 2014
Contact information	Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital, Charlestown, Massachusetts, USA
Notes	NCT02208466