NCT01503073

Brief Summary

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

Trial Health

53
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for not_applicable stroke

Timeline
56mo left

Started Jan 2008

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
suspended

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 Progress80%
Jan 2008Dec 2030

Study Start

First participant enrolled

January 1, 2008

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
13.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

17.9 years

First QC Date

December 23, 2011

Last Update Submit

May 8, 2023

Conditions

Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

  • change in function before/after tDCS

    any brain function impaired by stroke

    Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months

Secondary Outcomes (1)

  • change in neuroimaging and neurophysiological before/after tDCS

    Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months

Study Arms (2)

Real stimulation

ACTIVE COMPARATOR

real NIBS

Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Sham stimulation

SHAM COMPARATOR

sham NIBS

Device: tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Interventions

tdcs (ELDITH, Neuroconn, Ilmenau, Germany)DEVICE

transcranial direct current stimulation

Real stimulationSham stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • stroke with at least slight deficit

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, CHU Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Related Publications (2)

  • 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

  • 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.

    PMID: 23486918DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

December 23, 2011

First Posted

January 2, 2012

Study Start

January 1, 2008

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

BE(1)