NCT00853866

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

December 10, 2024

Status Verified

August 1, 2017

Enrollment Period

10 months

First QC Date

February 27, 2009

Last Update Submit

December 5, 2024

Conditions

Cerebral Stroke

Keywords

strokereboxetinenoradrenalinemotor cortextranscranial direct current stimulationmotor functionrehabilitationJebsen Taylor test

Outcome Measures

Primary Outcomes (1)

  • JTT

    Jebsen Taylor test

    crossover design, four different sessions with four different interventions

Secondary Outcomes (2)

  • Force

    crossover design, four different sessions with four different interventions

  • NHPT

    crossover design, four different sessions with four different interventions

Study Arms (4)

RBX + tDCS

EXPERIMENTAL

reboxetine + tDCS verum

Drug: reboxetineDevice: tDCS verum

RBX + sham stimulation

ACTIVE COMPARATOR

reboxetine + sham tDCS

Drug: reboxetineDevice: tDCS sham

PLC + tDCS

ACTIVE COMPARATOR

placebo drug + verum tDCS

Drug: PlaceboDevice: tDCS verum

PLC + sham stimulation

SHAM COMPARATOR

placebo drug + sham tDCS

Drug: PlaceboDevice: tDCS sham

Interventions

reboxetineDRUG

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

Also known as: brand name: Edronax, serial number: KPR 08092410/11
RBX + sham stimulationRBX + tDCS
PlaceboDRUG

placebo, 80 min before assessment of Jebsen Taylor test

Also known as: placebo drug resembling Edronax
PLC + sham stimulationPLC + tDCS
tDCS verumDEVICE

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

Also known as: Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau, Serialnumber: 0006
PLC + tDCSRBX + tDCS
tDCS shamDEVICE

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

Also known as: Hersteller:, DC Stimulator, Manufacturer:, eldith -Electro-Diagnostic & Therapeutic Systems GmbH, Gustav-Kirchhoff-Straße 5, D-98693 Ilmenau, Serialnumber: 0006
PLC + sham stimulationRBX + sham stimulation

Eligibility Criteria

Age18 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hamburg-Eppendorf, Department of Neurology

Hamburg, Hamburg, 20246, Germany

Location

Related Publications (7)

  • 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.

    PMID: 15634731BACKGROUND

  • 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.

    PMID: 15673839BACKGROUND

  • 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.

    PMID: 17083730BACKGROUND

  • 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.

    PMID: 16767410BACKGROUND

  • 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.

    PMID: 15184632BACKGROUND

  • 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.

    PMID: 12270635BACKGROUND

  • 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.

    PMID: 33175411DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Reboxetine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Christian Gerloff, MD

    Department of Neurology, University Hospital Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2009

First Posted

March 2, 2009

Study Start

January 1, 2009

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

December 10, 2024

Record last verified: 2017-08

Locations

DE(1)