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Effect of tDCS on Brain Organization and Motor Recovery (ESTCORM)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
DC-stimulator (Neuroconn, Germany)
Sponsored by
Adrian Guggisberg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke
  • ≤ 4 weeks after stroke onset
  • Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry
  • Capable of participating during treatment sessions of 30-60 minutes
  • Informed consent obtained

Exclusion Criteria:

  • Incapacity to understand study information or task instructions during trial.
  • New additional stroke during rehabilitation
  • Reduced vigilance or delirium
  • Severe language deficits
  • Preexisting affection of an upper limb
  • Severe spasticity or dystonia
  • Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease)
  • Pregnancy
  • Pacemaker
  • Skull breach
  • History of seizures or epilepsy
  • Metallic object in the brain
  • Other contraindication to non-invasive brain stimulation

Sites / Locations

  • Division of Neurorehabilitation, University Hospital of GenevaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Anodal tDCS

High definition (HD) anodal tDCS

Bihemispheric tDCS

Sham tDCS

Arm Description

The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.

A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode.

The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere.

The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability.

Outcomes

Primary Outcome Measures

Change in upper extremity Fugl-Meyer score, after intervention
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists

Secondary Outcome Measures

Change in EEG functional connectivity, after intervention
EEG functional connectivity between ipsilesional motor cortex and the rest of the brain, as computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Change in amplitude of motor evoked potentials, after intervention
Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome.

Full Information

First Posted
November 6, 2017
Last Updated
October 3, 2022
Sponsor
Adrian Guggisberg
Collaborators
University Hospital, Geneva, Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT03342534
Brief Title
Effect of tDCS on Brain Organization and Motor Recovery
Acronym
ESTCORM
Official Title
Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2017 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Adrian Guggisberg
Collaborators
University Hospital, Geneva, Clinique Romande de Readaptation, Ecole Polytechnique Fédérale de Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Neurological deficits and motor disorders are extremely common after stroke. Physical therapies can improve the autonomy of these patients, but despite an intensive stationary neurorehabilitation, severe deficits often persist. Complementary therapies that could improve recovery would therefore be very welcome. Transcranial direct current stimulation (tDCS) induces, in a non-invasive way, a transient inhibitory or excitatory neuromodulation of certain cerebral regions. An increasing number of studies show that this modulation of brain activity can improve motor functions in patients with brain lesions and increase the effect of physical therapies. However, the "optimum" configuration of tDCS and the induced effects remain to be characterized and investigated. The investigators therefore propose to carry out a study including a pilot phase in order to determine the most efficient tDCS setup. The optimum setup of of the pilot phase will be compared to a placebo condition in a multicentric main study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.
Arm Title
High definition (HD) anodal tDCS
Arm Type
Active Comparator
Arm Description
A single HD anode is placed over the primary motor cortex of the stroke affected hemisphere, 4 HD cathodes are placed over the affected hemisphere around the anode.
Arm Title
Bihemispheric tDCS
Arm Type
Active Comparator
Arm Description
The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the primary motor cortex of the contralesional hemisphere.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
The electrodes are placed as in one of the active arms, but only a ramp up current is applied during 30 seconds and then switched off. This induces similar sensations for the patients, but no change in excitability.
Intervention Type
Device
Intervention Name(s)
DC-stimulator (Neuroconn, Germany)
Intervention Description
A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
Primary Outcome Measure Information:
Title
Change in upper extremity Fugl-Meyer score, after intervention
Description
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before the intervention and the week after intervention
Secondary Outcome Measure Information:
Title
Change in EEG functional connectivity, after intervention
Description
EEG functional connectivity between ipsilesional motor cortex and the rest of the brain, as computed from high-density EEG recordings. Continuous measure. Higher values indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in amplitude of motor evoked potentials, after intervention
Description
Motor evoked potentials are obtained with single-pulse transcranial magnetic stimulation. Continuous measure expressed in microvolts, more microvolts indicate better outcome.
Time Frame
Difference between the week before the intervention and the week after intervention
Other Pre-specified Outcome Measures:
Title
Change in upper extremity Fugl-Meyer score, follow up 1
Description
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 4 weeks after intervention
Title
Change in upper extremity Fugl-Meyer score, follow up 2
Description
Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Jamar dynamometer, after intervention
Description
Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Jamar dynamometer, follow up 1
Description
Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 4 weeks after intervention
Title
Change in Jamar dynamometer, follow up 2
Description
Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Nine-Hole-Peg test, after intervention
Description
Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Nine-Hole-Peg test, follow up 1
Description
Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
Time Frame
Difference between the week before intervention and 4 weeks after intervention
Title
Change in Nine-Hole-Peg test, follow up 2
Description
Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in action research arm test (ARAT) score, after intervention
Description
Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in action research arm test (ARAT) score, follow up 1
Description
Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 4 weeks after intervention
Title
Change in action research arm test (ARAT) score, follow up 2
Description
Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset
Title
Change in Functional Independence Measure (FIM) score, after intervention
Description
Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.
Time Frame
Difference between the week before the intervention and the week after intervention
Title
Change in Functional Independence Measure (FIM) score, follow up 1
Description
Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.
Time Frame
Difference between the week before intervention and 4 weeks after intervention
Title
Change in Functional Independence Measure (FIM) score, follow up 2
Description
Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.
Time Frame
Difference between the week before intervention and 12 weeks after stroke onset

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ischemic or hemorrhagic stroke ≤ 4 weeks after stroke onset Paresis of upper limb with Fugl-Meyer score between 15 and 55 at study entry Capable of participating during treatment sessions of 30-60 minutes Informed consent obtained Exclusion Criteria: Incapacity to understand study information or task instructions during trial. New additional stroke during rehabilitation Reduced vigilance or delirium Severe language deficits Preexisting affection of an upper limb Severe spasticity or dystonia Severe co-morbidities (e.g., traumatic, rheumatologic, neurodegenerative disease) Pregnancy Pacemaker Skull breach History of seizures or epilepsy Metallic object in the brain Other contraindication to non-invasive brain stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adrian G Guggisberg, MD
Phone
+41223723521
Email
Adrian.Guggisberg@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
José Millán, PhD
Email
jose.millan@epfl.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Millán, PhD
Organizational Affiliation
Ecole Polytechnique Fédérale de Lausanne
Official's Role
Study Director
Facility Information:
Facility Name
Division of Neurorehabilitation, University Hospital of Geneva
City
Geneva
State/Province
GE
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD
Phone
+41223723521
Email
adrian.guggisberg@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Adrian G Guggisberg, MD

12. IPD Sharing Statement

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Effect of tDCS on Brain Organization and Motor Recovery

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