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

August 2, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

Entwicklung Neuronaler Repräsentationen Nach Schlaganfall: Verbesserung Motorischer Leistungen Durch Transkranielle Gleichstromstimulation Und Noradrenerge Co-Stimulation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • HH
      • Hamburg, HH, Germany, 20246
        • University Hospital Hamburg-Eppendorf, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 86 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 86
  • patient is contractually capable
  • first-ever, ischemic stroke
  • minimum time since stroke 9 months
  • a paresis of the arm/hand muscles above 3 on the MRC scale

Exclusion Criteria:

  • multiple cerebral lesions and associated residual deficits
  • severe head trauma in the past
  • seizures
  • ferromagnetic implants in the head/neck region
  • pacemaker
  • a psychiatric disorder or neurological disease besides stroke
  • intake of illegal drugs
  • severe aphasia or cognitive deficits that impede contractual capability
  • contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with co-medication)
  • pregnancy
  • breast-feeding patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Jebsen Taylor test
Time Frame: crossover design, four different sessions with four different interventions
crossover design, four different sessions with four different interventions

Secondary Outcome Measures

Outcome Measure
Time Frame
maximum grip force
Time Frame: crossover design, four different sessions with four different interventions
crossover design, four different sessions with four different interventions
nine hole peg test
Time Frame: crossover design, four different sessions with four different interventions
crossover design, four different sessions with four different interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Collaborators

German Research Foundation
University Hospital Tuebingen

Investigators

  • Principal Investigator: Christian Gerloff, MD, Department of Neurology, University Hospital Hamburg-Eppendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (ESTIMATE)

March 2, 2009

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-00160436-36
  • 28/2005AMG1
  • IMPACS-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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