Noninvasive Brain Stimulation for Stroke

NCT ID: NCT01503073

Last Updated: 2023-05-09

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2030-12-31

Brief Summary

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Noninvasive brain stimulations will be used in acute and chronic stroke patients to improve a variety of functions.

Detailed Description

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Noninvasive brain stimulations (NIBS) will be used in acute and chronic stroke patients to improve a variety of functions such as motor functions, cognitive functions, ...

NIBS will be applied in a placebo-controlled, double-blind, randomised fashion. Behavioural data will be collected before and after NIBS, as well as brain functional imaging data.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Real stimulation

real NIBS

Group Type ACTIVE_COMPARATOR

tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Intervention Type DEVICE

transcranial direct current stimulation

Sham stimulation

sham NIBS

Group Type SHAM_COMPARATOR

tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Intervention Type DEVICE

transcranial direct current stimulation

Interventions

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tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

transcranial direct current stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* stroke with at least slight deficit

Exclusion Criteria

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* unability to understand / complete behavioural tasks
* chronic intake of alcohol or recreative drugs
* major health condition
* presence of pacemaker
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of Mont-Godinne

OTHER

Sponsor Role lead

Responsible Party

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Pr Yves Vandermeeren, MD, PhD

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurology, CHU Mont-Godinne

Yvoir, Namur, Belgium

Site Status

Countries

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Belgium

References

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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)

Lefebvre S, Thonnard JL, Laloux P, Peeters A, Jamart J, Vandermeeren Y. Single session of dual-tDCS transiently improves precision grip and dexterity of the paretic hand after stroke. Neurorehabil Neural Repair. 2014 Feb;28(2):100-10. doi: 10.1177/1545968313478485. Epub 2013 Mar 13.

Reference Type DERIVED
PMID: 23486918 (View on PubMed)

Other Identifiers

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B03920073136

Identifier Type: -

Identifier Source: org_study_id

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