Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation

Cerebral Stroke Clinical Trial

— STIMBOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853866
• Other study ID #: 2005-00160436-36
• Secondary ID: 28/2005AMG1IMPAC
• Status: Completed
• Phase: Phase 4
• First received: February 27, 2009
• Last updated: August 2, 2017
• Start date: January 2009
• Est. completion date: June 2010

Study information

• Verified date: August 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Drug:
• reboxetine
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
• 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
• 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

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf, Department of Neurology	Hamburg	HH

Sponsors (3)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	German Research Foundation, University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. Epub 2005 Jan 5. — View Citation

Hummel F, Cohen LG. Improvement of motor function with noninvasive cortical stimulation in a patient with chronic stroke. Neurorehabil Neural Repair. 2005 Mar;19(1):14-9. — View Citation

Hummel FC, Voller B, Celnik P, Floel A, Giraux P, Gerloff C, Cohen LG. Effects of brain polarization on reaction times and pinch force in chronic stroke. BMC Neurosci. 2006 Nov 3;7:73. — View Citation

Plewnia C, Hoppe J, Cohen LG, Gerloff C. Improved motor skill acquisition after selective stimulation of central norepinephrine. Neurology. 2004 Jun 8;62(11):2124-6. — View Citation

Plewnia C, Hoppe J, Gerloff C. No effects of enhanced central norepinephrine on finger-sequence learning and attention. Psychopharmacology (Berl). 2006 Aug;187(2):260-5. Epub 2006 Jun 10. — View Citation

Plewnia C, Hoppe J, Hiemke C, Bartels M, Cohen LG, Gerloff C. Enhancement of human cortico-motoneuronal excitability by the selective norepinephrine reuptake inhibitor reboxetine. Neurosci Lett. 2002 Sep 27;330(3):231-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Jebsen Taylor test		crossover design, four different sessions with four different interventions
Secondary	maximum grip force		crossover design, four different sessions with four different interventions
Secondary	nine hole peg test		crossover design, four different sessions with four different interventions

External Links

•   Homepage Brain Imaging and Neurostimulation Lab, Department of Neurology, University Hospital Hamburg-Eppendorf