Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation "STIMBOX"

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: placebo, 80 min before assessment of Jebsen Taylor test
    ARM 1: Kind: Experimental
    Label: 3
    Description: placebo drug + verum tDCS
    ARM 2: Kind: Experimental
    Label: 4
    Description: placebo drug + sham tDCS
  • Reboxetine Drug
    Other Names: brand name: Edronax, serial number: KPR 08092410/11
    Intervention Desc: single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
    ARM 1: Kind: Experimental
    Label: 1
    Description: reboxetine + tDCS verum
    ARM 2: Kind: Experimental
    Label: 2
    Description: reboxetine + sham tDCS
  • TDCS verum Device
    Other Names: Hersteller:; DC Stimulator; Manufacturer:; eldith -Electro-Diagnostic & Therapeutic Systems GmbH; Gustav-Kirchhoff-Straße 5; D-98693 Ilmenau; Serialnumber: 0006
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: 1
    Description: reboxetine + tDCS verum
    ARM 2: Kind: Experimental
    Label: 3
    Description: placebo drug + verum tDCS
  • TDCS sham Device
    Other Names: Hersteller:; DC Stimulator; Manufacturer:; eldith -Electro-Diagnostic & Therapeutic Systems GmbH; Gustav-Kirchhoff-Straße 5; D-98693 Ilmenau; Serialnumber: 0006
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: 2
    Description: reboxetine + sham tDCS
    ARM 2: Kind: Experimental
    Label: 4
    Description: placebo drug + sham tDCS

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Crossover Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Jebsen Taylor test crossover design, four different sessions with four different interventions No
Secondary maximum grip force crossover design, four different sessions with four different interventions No
Secondary nine hole peg test crossover design, four different sessions with four different interventions No

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