Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation (STIMBOX)
Primary Purpose
Cerebral Stroke
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
reboxetine
Placebo
tDCS verum
tDCS sham
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke focused on measuring stroke, reboxetine, noradrenaline, motor cortex, transcranial direct current stimulation, motor function, rehabilitation, Jebsen Taylor test
Eligibility Criteria
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
Sites / Locations
- University Hospital Hamburg-Eppendorf, Department of Neurology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
reboxetine + tDCS verum
reboxetine + sham tDCS
placebo drug + verum tDCS
placebo drug + sham tDCS
Outcomes
Primary Outcome Measures
Jebsen Taylor test
Secondary Outcome Measures
maximum grip force
nine hole peg test
Full Information
NCT ID
NCT00853866
First Posted
February 27, 2009
Last Updated
August 2, 2017
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT00853866
Brief Title
Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation
Acronym
STIMBOX
Official Title
Entwicklung Neuronaler Repräsentationen Nach Schlaganfall: Verbesserung Motorischer Leistungen Durch Transkranielle Gleichstromstimulation Und Noradrenerge Co-Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
German Research Foundation, University Hospital Tuebingen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke
Keywords
stroke, reboxetine, noradrenaline, motor cortex, transcranial direct current stimulation, motor function, rehabilitation, Jebsen Taylor test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
reboxetine + tDCS verum
Arm Title
2
Arm Type
Experimental
Arm Description
reboxetine + sham tDCS
Arm Title
3
Arm Type
Experimental
Arm Description
placebo drug + verum tDCS
Arm Title
4
Arm Type
Experimental
Arm Description
placebo drug + sham tDCS
Intervention Type
Drug
Intervention Name(s)
reboxetine
Other Intervention Name(s)
brand name: Edronax, serial number: KPR 08092410/11
Intervention Description
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, 80 min before assessment of Jebsen Taylor test
Intervention Type
Device
Intervention Name(s)
tDCS verum
Other Intervention Name(s)
Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau, Serialnumber: 0006
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
tDCS sham
Other Intervention Name(s)
Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau, Serialnumber: 0006
Intervention Description
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
Primary Outcome Measure Information:
Title
Jebsen Taylor test
Time Frame
crossover design, four different sessions with four different interventions
Secondary Outcome Measure Information:
Title
maximum grip force
Time Frame
crossover design, four different sessions with four different interventions
Title
nine hole peg test
Time Frame
crossover design, four different sessions with four different interventions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
86 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Gerloff, MD
Organizational Affiliation
Department of Neurology, University Hospital Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Hamburg-Eppendorf, Department of Neurology
City
Hamburg
State/Province
HH
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
15634731
Citation
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. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
Results Reference
background
PubMed Identifier
15673839
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. doi: 10.1177/1545968304272698.
Results Reference
background
PubMed Identifier
17083730
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. doi: 10.1186/1471-2202-7-73.
Results Reference
background
PubMed Identifier
16767410
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. doi: 10.1007/s00213-006-0420-5. Epub 2006 Jun 10.
Results Reference
background
PubMed Identifier
15184632
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. doi: 10.1212/01.wnl.0000128041.92710.17.
Results Reference
background
PubMed Identifier
12270635
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. doi: 10.1016/s0304-3940(02)00803-0.
Results Reference
background
PubMed Identifier
33175411
Citation
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Results Reference
derived
Links:
URL
https://www.uke.de/english/departments-institutes/departments/neurology/research/index.html
Description
Homepage Brain Imaging and Neurostimulation Lab, Department of Neurology, University Hospital Hamburg-Eppendorf
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Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation
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