NCT02512289

Brief Summary

tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

2 active sites

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 9, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2015

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

Same day

First QC Date

August 25, 2014

Last Update Submit

August 23, 2018

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Upper Limb Kinematics

    kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Secondary Outcomes (2)

  • Box and Block test

    Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

  • Purdue Pegboard Test

    Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)

Study Arms (2)

Real stimulation

ACTIVE COMPARATOR

real tDCS associated with robot-assisted therapy (RAT)

Device: tDCS (ELDITH) and RAT (REAplan)

Sham stimulation

SHAM COMPARATOR

Sham tDCS associated with RAT

Device: tDCS (ELDITH) and RAT (REAplan)

Interventions

tDCS (ELDITH) and RAT (REAplan)DEVICE

Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan

Real stimulationSham stimulation

Eligibility Criteria

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

You may qualify if:

  • stroke with at least slight deficit in upper limb

You may not qualify if:

  • epilepsy
  • contraindication to tDCS
  • presence of metal in the head
  • inability to understand/complete behavioural tasks
  • chronic intake of alcohol or recreative drugs
  • major health condition (e.g. terminal renal failure, instable heart failure etc …)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

CHU Dinant-Godinne UCL

Mont Godinne, Belgium

Location

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 Officials

  • Thierry Lejeune, Professor

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

July 30, 2015

Study Start

January 9, 2014

Primary Completion

January 9, 2014

Study Completion

July 30, 2015

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

BE(2)