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Enhancement of Motor Function with Reboxetine and Transcranial Direct Current Stimulation

NCT ID: NCT00853866

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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

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Cerebral Stroke

Keywords

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stroke reboxetine noradrenaline motor cortex transcranial direct current stimulation motor function rehabilitation Jebsen Taylor test

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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RBX + tDCS

reboxetine + tDCS verum

Group Type EXPERIMENTAL

reboxetine

Intervention Type DRUG

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

tDCS verum

Intervention Type DEVICE

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

RBX + sham stimulation

reboxetine + sham tDCS

Group Type ACTIVE_COMPARATOR

reboxetine

Intervention Type DRUG

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

tDCS sham

Intervention Type DEVICE

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

PLC + tDCS

placebo drug + verum tDCS

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

placebo, 80 min before assessment of Jebsen Taylor test

tDCS verum

Intervention Type DEVICE

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

PLC + sham stimulation

placebo drug + sham tDCS

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DRUG

placebo, 80 min before assessment of Jebsen Taylor test

tDCS sham

Intervention Type DEVICE

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

Interventions

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reboxetine

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

Intervention Type DRUG

Placebo

placebo, 80 min before assessment of Jebsen Taylor test

Intervention Type DRUG

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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brand name: Edronax, serial number: KPR 08092410/11 placebo drug resembling Edronax Hersteller: DC Stimulator Manufacturer: eldith -Electro-Diagnostic & Therapeutic Systems GmbH Gustav-Kirchhoff-Straße 5 D-98693 Ilmenau Serialnumber: 0006 Hersteller: DC Stimulator Manufacturer: eldith -Electro-Diagnostic & Therapeutic Systems GmbH Gustav-Kirchhoff-Straße 5 D-98693 Ilmenau Serialnumber: 0006

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Gerloff, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Hospital Hamburg-Eppendorf

Locations

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University Hospital Hamburg-Eppendorf, Department of Neurology

Hamburg, City state of Hamburg, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 15634731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15673839 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17083730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16767410 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15184632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12270635 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Related Links

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https://www.uke.de/english/departments-institutes/departments/neurology/research/index.html

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

Other Identifiers

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28/2005AMG1

Identifier Type: OTHER

Identifier Source: secondary_id

SFB550 TPC5

Identifier Type: OTHER

Identifier Source: secondary_id

2005-00160436-36

Identifier Type: -

Identifier Source: org_study_id