NCT00853866.
Trial name or title | Enhancement of motor function with reboxetine and transcranial direct current stimulation (STIMBOX) |
Methods | Randomised sham‐controlled double‐blind cross‐over trial |
Participants | 12 people with stroke between 18 and 86 years of age, able to give informed consent, with first‐ever ischaemic stroke at least 6 months before study enrolment and paresis of arm/hand muscles above 3 on MRC scale Exclusion criteria: multiple cerebral lesions with associated residual deficits, severe head trauma, seizures, ferromagnetic implants in the head/neck region, pacemaker, other psychiatric or neurological diseases, substance abuse, inability to give informed consent, contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with comedication), pregnancy and breast‐feeding |
Interventions | Experimental group 1: reboxetine + active tDCS: single dose of reboxetine/edrona × 4 mg 80 minutes before assessment of JTT + 20 minutes of 1 mA tDCS during JTFHT assessment with the active electrode over M1 of the lesioned hemisphere Experimental group 2: reboxetine + sham tDCS: single dose of reboxetine/edrona × 4 mg 80 minutes before assessment of JTT + 30 seconds of 1 mA tDCS during JTFHT assessment with the active electrode over M1 of the lesioned hemisphere Experimental group 3: placebo drug + active tDCS: placebo 80 minutes before assessment of JTT + 20 minutes of 1 mA tDCS during JTFHT assessment with the active electrode over M1 of the lesioned hemisphere Experimental group 4: placebo drug + sham tDCS: placebo 80 minutes before assessment of JTT + 30 s of 1 mA tDCS during JTFHT assessment with the active electrode over M1of the lesioned hemisphere |
Outcomes | Primary outcome measures: Jebsen Taylor Test at 4 different sessions with 4 different interventions Secondary outcome measures: maximum grip force at 4 different sessions with 4 different interventions; Nine‐Hole Peg Test at 4 different sessions with 4 different interventions |
Starting date | January 2009 |
Contact information | Contact: GianpieroLiuzzi, MD +49 40 7410 ext 59278 g.liuzzi@uke.de Contact: Christian Gerloff, MD + 49 40 7410 ext 53770 gerloff@uke.de |
Notes | Last updated: 1 December 2010 |