Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation (STIMBOX)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cerebral Stroke |
Drug: reboxetine Drug: Placebo Device: tDCS verum Device: tDCS sham |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Entwicklung Neuronaler Repräsentationen Nach Schlaganfall: Verbesserung Motorischer Leistungen Durch Transkranielle Gleichstromstimulation Und Noradrenerge Co-Stimulation |
- Jebsen Taylor test [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]
- maximum grip force [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]
- nine hole peg test [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
reboxetine + tDCS verum
|
Drug: reboxetine
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
Other Name: 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:
|
|
Experimental: 2
reboxetine + sham tDCS
|
Drug: reboxetine
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
Other Name: 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:
|
|
Experimental: 3
placebo drug + verum tDCS
|
Drug: Placebo
placebo, 80 min before assessment of Jebsen Taylor test
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:
|
|
Experimental: 4
placebo drug + sham tDCS
|
Drug: Placebo
placebo, 80 min before assessment of Jebsen Taylor test
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:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 86 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Gianpiero Liuzzi, MD | +49 40 7410 ext 59278 | g.liuzzi@uke.de |
| Contact: Christian Gerloff, MD | + 49 40 7410 ext 53770 | gerloff@uke.de |
| Germany | |
| University Hospital Hamburg-Eppendorf, Department of Neurology | Recruiting |
| Hamburg, HH, Germany, 20246 | |
| Contact: Gianpiero Liuzzi, MD +49 40 7410 ext 59278 g.liuzzi@uke.de | |
| Contact: Christian Gerloff, MD +49 40 7410 ext 53770 gerloff@uke.de | |
| Sub-Investigator: Gianpiero Liuzzi, MD | |
| Principal Investigator: Christian Gerloff, MD | |
| Sub-Investigator: Julia Hoppe, MD | |
| Sub-Investigator: Friedhelm C Hummel, MD | |
| Sub-Investigator: Kirstin F Heise, MSc | |
| Principal Investigator: | Christian Gerloff, MD | Department of Neurology, University Hospital Hamburg-Eppendorf |
More Information
Additional Information:
Publications:
| Responsible Party: | Prof. Dr. C. Gerloff, Department of Neurology, University Hospital Hamburg-Eppendorf |
| ClinicalTrials.gov Identifier: | NCT00853866 History of Changes |
| Other Study ID Numbers: | 2005-00160436-36, 28/2005AMG1, IMPACS-01 |
| Study First Received: | February 27, 2009 |
| Last Updated: | December 1, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
|
stroke reboxetine noradrenaline motor cortex |
transcranial direct current stimulation motor function rehabilitation Jebsen Taylor test |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia Reboxetine |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Adrenergic Uptake Inhibitors Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013