search
Back to results

Effects of tDCS on Quadriceps Strength After Stroke (tDCS(HE))

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial Direct current stimulation
Sponsored by
Centre d'Investigation Clinique et Technologique 805
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, Stroke, Force, Spasticity, Gait, EMG, Isokinetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • written consent
  • hemiparetic patient after stroke in chronic phase (> 6 months)
  • capacity to walk with or without technical assistance
  • following rehabilitation program for lower limbs

Exclusion Criteria:

  • patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia
  • previous orthopedic surgery in paretic lower limb (<6 moths)
  • usual tDCS contraindications
  • pregnant woman

Sites / Locations

  • Raymond Poincare Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

hemiplegic patient

patient control

Arm Description

anodal transcranial direct current stimulation

Sham transcranial direct current stimulation

Outcomes

Primary Outcome Measures

maximum voluntary isometric strength of knee extensors
The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.

Secondary Outcome Measures

Resistive peak torque during passive knee flexion
Angle related to the resistive peak torque generation of the knee extensors
Amplitude of the interpolation twitch
EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
Functional evaluation of the gait performance and balance

Full Information

First Posted
April 8, 2014
Last Updated
November 10, 2017
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
search

1. Study Identification

Unique Protocol Identification Number
NCT02109796
Brief Title
Effects of tDCS on Quadriceps Strength After Stroke
Acronym
tDCS(HE)
Official Title
a Controlled, Randomized Study Evaluating the Immediate Effect of One tDCS Session on Quadriceps Strength in Hemiparetic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
February 19, 2015 (Actual)
Primary Completion Date
November 28, 2016 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Previous studies show that one session of tDCS allow to improve muscle strength in hemiparetic patients in anodal condition. We test a new electrods configuration : a anodale stimulation opposite to the cortical representation area of the injured hemisphere and a simultaneous stimulation opposite to the homonyme the cortical representation area of the healthy hemisphere. This approach seems to be the best relevant electrods configuration in order to restore the inter-hemispheric balance. We hypothesis that one session of tDCS with this electrods configuration allow to improve paretic quadriceps strength in hemiparetic patients after stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
tDCS, Stroke, Force, Spasticity, Gait, EMG, Isokinetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hemiplegic patient
Arm Type
Experimental
Arm Description
anodal transcranial direct current stimulation
Arm Title
patient control
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
transcranial Direct current stimulation
Primary Outcome Measure Information:
Title
maximum voluntary isometric strength of knee extensors
Description
The maximum voluntary isometric strength of paretic knee extensors will be evaluated with a isokinetic dynamometer, which measure peak torque.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Resistive peak torque during passive knee flexion
Time Frame
2h
Title
Angle related to the resistive peak torque generation of the knee extensors
Time Frame
2h
Title
Amplitude of the interpolation twitch
Time Frame
2h
Title
EMG activation of the knee flexors and extensors during the strength evaluations (active and passive)
Time Frame
2h
Title
Functional evaluation of the gait performance and balance
Time Frame
2h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: written consent hemiparetic patient after stroke in chronic phase (> 6 months) capacity to walk with or without technical assistance following rehabilitation program for lower limbs Exclusion Criteria: patient with bilateral brain lesion, cerebellar syndrom, and apraxia and/or aphasia previous orthopedic surgery in paretic lower limb (<6 moths) usual tDCS contraindications pregnant woman
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roche Nicolas, MD PH
Organizational Affiliation
Raymond Poincaré Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bensmail Djamel, MD PH
Organizational Affiliation
Raymond Poincare Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raymond Poincare Hospital
City
Garches
ZIP/Postal Code
92380
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33175411
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of tDCS on Quadriceps Strength After Stroke

We'll reach out to this number within 24 hrs