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Cerebral StrokePhase 4STIMBOXNCT00853866

Enhancement of Motor Function with Reboxetine and Transcranial Direct Current Stimulation

A Phase 4 study testing reboxetine and tDCS verum in people with Cerebral Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 86 years
Conditions the study is for
Cerebral Stroke
What is being tested?
reboxetine and tDCS verum
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteGermany
Study dates
Jan 2009to Jun 2010
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 86 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Hospital Hamburg-Eppendorf, Department of Neurology

    Hamburg, Free and Hanseatic City of Hamburg, 20246

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Conditions
Cerebral Stroke
Being tested
reboxetine, Placebo, tDCS verum, tDCS sham
Keywords
stroke, reboxetine, noradrenaline, motor cortex, transcranial direct current stimulation, motor function, rehabilitation, Jebsen Taylor test
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • reboxetineDrug

    Also called brand name: Edronax, serial number: KPR 08092410/11

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

  • PlaceboDrug

    Also called placebo drug resembling Edronax

    placebo, 80 min before assessment of Jebsen Taylor test

  • tDCS verumDevice

    Also called Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH

    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 shamDevice

    Also called Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH

    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

Study groups in NCT00853866
Study groupRoleWhat they receive
RBX + tDCSExperimentalreboxetine + tDCS verum
Receives: Drug: reboxetine; Device: tDCS verum
RBX + sham stimulationActive comparatorreboxetine + sham tDCS
Receives: Drug: reboxetine; Device: tDCS sham
PLC + tDCSActive comparatorplacebo drug + verum tDCS
Receives: Drug: Placebo; Device: tDCS verum
PLC + sham stimulationSham comparatorplacebo drug + sham tDCS
Receives: Drug: Placebo; Device: tDCS sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. JTT

    Jebsen Taylor test

    Measured: crossover design, four different sessions with four different interventions

Secondary outcomes (2)

  1. Force

    maximum grip force

    Measured: crossover design, four different sessions with four different interventions

  2. NHPT

    nine hole peg test

    Measured: crossover design, four different sessions with four different interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionNov 2009
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00853866
Sponsor's protocol ID
2005-00160436-36
Other IDs
28/2005AMG1, SFB550 TPC5, 2005
Acronym
STIMBOX
Status last verified
Aug 2017
First submitted
27 Feb 2009
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 15634731

  • 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.

    PubMed 15673839

  • 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.

    PubMed 17083730

  • 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.

    PubMed 16767410

  • 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.

    PubMed 15184632

  • 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.

    PubMed 12270635

  • 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.

    PubMed 33175411

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing reboxetine and tDCS verum in people with Cerebral Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

JTT (time frame: crossover design, four different sessions with four different interventions). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853866, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.

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