NCT01519843

Brief Summary

Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning. Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.

Trial Health

53
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
100

participants targeted

Target at P75+ for not_applicable stroke

Timeline
56mo left

Started Sep 2010

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 Progress77%
Sep 2010Dec 2030

Study Start

First participant enrolled

September 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 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

15.3 years

First QC Date

January 19, 2012

Last Update Submit

May 8, 2023

Conditions

StrokeHemiparesis

Keywords

stroke

Outcome Measures

Primary Outcomes (1)

  • Motor learning improvement with tDCS

    performance on a motor skill learning task and on different commonly used task (Purdue Pegboard, hand dynamometer, pinch dynamometer, 9-HPT ,...) were measured to explore the impact of tDCS on these parameters

    Improvement on motor learning were recorded from baseline to 4 weeks after the intervention

Secondary Outcomes (2)

  • Neuroimaging

    before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)

  • Neurophysiological outcome measure

    start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)

Study Arms (2)

Real

ACTIVE COMPARATOR

Real tDCS

Device: transcranial direct current stimulation tDCSDevice: transcranial magnetic stimulation TMS

sham

PLACEBO COMPARATOR

Sham tDCS

Device: transcranial direct current stimulation tDCSDevice: transcranial magnetic stimulation TMS

Interventions

transcranial direct current stimulation tDCSDEVICE

tdcs (ELDITH, Neuroconn, Ilmenau, Germany)

Realsham
transcranial magnetic stimulation TMSDEVICE

TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand

Realsham

Eligibility Criteria

Age18 Years - 95 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
  • inability to understand / complete behavioral tasks
  • chronic intake of alcohol or recreational drugs
  • major health condition
  • presence of pacemaker (for the fMRI part only)
  • 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 (2)

  • Riga A, Gathy E, Ghinet M, De Laet C, Bihin B, Regnier M, Leeuwerck M, De Coene B, Dricot L, Herman B, Edwards MG, Vandermeeren Y. Evidence of Motor Skill Learning in Acute Stroke Patients Without Lesions to the Thalamus and Internal Capsule. Stroke. 2022 Jul;53(7):2361-2368. doi: 10.1161/STROKEAHA.121.035494. Epub 2022 Mar 21.

    PMID: 35311345DERIVED

  • 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

MeSH Terms

Conditions

StrokeParesis

Interventions

Transcranial Direct Current StimulationTranscranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological TechniquesMagnetic Field Therapy

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

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 27, 2012

Study Start

September 1, 2010

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2030

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations

BE(1)