Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation
Condition: Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of the study is that combination of reboxetine/tDCS is more effective in
      enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to
      reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized
      placebo-controlled double-blind crossover study.
    

Detailed description: 
      One important feature of the human brain is the ability to undergo plastic changes and
      reorganization after learning and lesions of the nervous system. This ability is of major
      importance for the treatment of functional deficits after stroke. Stroke is the major disease
      leading to persistent functional disabilities in Germany. However, the success rate of
      therapeutic interventions, especially in chronic stroke patients, is still unsatisfactory.
      Thus, basic science is essential to discover new therapeutic options that bear the potential
      for translation into clinical practice. Recent evidence is pointing to modulating the motor
      cortical excitability in order to enhance motor function in stroke patients. For this
      purpose, reboxetine as a selective reuptake inhibitor of noradrenaline and transcranial
      direct current stimulation have proven effective in enhancing motor functions needed for
      daily life activities by 10-12%. These improvements were significant compared to placebo, but
      still clinically unsatisfactory. Thus, this protocol aims at enhancing the excitability
      modulatory effect of each single intervention through the combination of reboxetine and tDCS.
      The hypothesis of the study is that combination of reboxetine/tDCS is more effective in
      enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to
      reboxetine and tDCS alone.

      The protocol is designed as a within-subject, block randomized placebo-controlled
      double-blind crossover study. 12 chronic stroke patients with persistent functional deficits
      of the arm and/or hand will be included. The primary outcome measure is the time needed to
      fulfill all subtests of the Jebsen Taylor test. All patients undergo four different
      conditions in four different sessions: 1) reboxetine + verum tDCS; 2) reboxetine + sham tDCS
      3) placebo drug + verum tDCS 4) placebo drug + sham tDCS.
    

Intervention name(s): reboxetine; Placebo; tDCS verum; tDCS sham
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test; placebo, 80 min before assessment of Jebsen Taylor test; 20 minutes of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test; 30 seconds of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
Other intervention name(s): brand name: Edronax, serial number: KPR 08092410/11; Hersteller:; DC Stimulator; Manufacturer:; eldith -Electro-Diagnostic & Therapeutic Systems GmbH; Gustav-Kirchhoff-Straße 5; D-98693 Ilmenau; Serialnumber: 0006; Hersteller:; DC Stimulator; Manufacturer:; eldith -Electro-Diagnostic & Therapeutic Systems GmbH; Gustav-Kirchhoff-Straße 5; D-98693 Ilmenau; Serialnumber: 0006
Intervention MeSH terms: Reboxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; reboxetine; noradrenaline; motor cortex; transcranial direct current stimulation; motor function; rehabilitation; Jebsen Taylor test