NCT01544699

Brief Summary

tDCS (transcranial direct current stimulation) will be used in chronic stroke patients to improve a variety of functions with superior or inferior limb.

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
44mo left

Started Jan 2012

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 2012Jan 2030

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2012

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Expected
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

13.9 years

First QC Date

February 10, 2012

Last Update Submit

January 9, 2024

Conditions

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

  • change in motor function before/after tDCS

    Motor performance improvement with inferior or superior limb

    Baseline (>6 months after stroke), immediately after intervention (30min of tDCS), 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks

Study Arms (2)

Real stimulation

ACTIVE COMPARATOR

real tDCS (well, that's the way it is I am not gonna change it)

Device: tDCS (ELDITH)

Sham

SHAM COMPARATOR

sham tDCS

Device: tDCS (ELDITH)

Interventions

tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation

Real stimulationSham

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 in superior or inferior limb

You may not qualify if:

  • epilepsy
  • contraindication to tDCS and/or to fMRI
  • presence of metal in the head
  • inability 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,, Belgium

Location

Related Publications (1)

  • 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.

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
Masking Details
no change
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: no change
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2012

First Posted

March 6, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2025

Study Completion (Estimated)

January 1, 2030

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations