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

Effects of Transcranial Direct Current Stimulation (tDCS) on Brain Organization and Motor Recovery After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: DC-stimulator (Neuroconn, Germany)

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José Millán, PhD; Email: jose.millan@epfl.ch
• Study Contact Backup: Name: Adrian G Guggisberg, MD; Phone Number: +41223723521; Email: adrian.guggisberg@hcuge.ch

Study Locations

• Switzerland
  • GE
    • Geneva, GE, Switzerland, 1211
      • Recruiting
      • Division of Neurorehabilitation, University Hospital of Geneva
      • Contact: Adrian G Guggisberg, MD; Phone Number: +41223723521; Email: adrian.guggisberg@hcuge.ch
      • Principal Investigator: Adrian G Guggisberg, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anodal tDCS; The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.	Device: DC-stimulator (Neuroconn, Germany); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
Active Comparator: High definition (HD) anodal tDCS; 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.	Device: DC-stimulator (Neuroconn, Germany); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
Active Comparator: Bihemispheric tDCS; 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.	Device: DC-stimulator (Neuroconn, Germany); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
Sham Comparator: Sham tDCS; 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.	Device: DC-stimulator (Neuroconn, Germany); A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Difference between the week before the intervention and the week after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Difference between the week before the intervention and the week after intervention
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.	Difference between the week before the intervention and the week after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in upper extremity Fugl-Meyer score, follow up 1	Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 4 weeks after intervention
Change in upper extremity Fugl-Meyer score, follow up 2	Scale range 0-66 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 12 weeks after stroke onset
Change in Jamar dynamometer, after intervention	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before the intervention and the week after intervention
Change in Jamar dynamometer, follow up 1	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 4 weeks after intervention
Change in Jamar dynamometer, follow up 2	Continous measure expressed in kilograms. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 12 weeks after stroke onset
Change in Nine-Hole-Peg test, after intervention	Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.	Difference between the week before the intervention and the week after intervention
Change in Nine-Hole-Peg test, follow up 1	Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.	Difference between the week before intervention and 4 weeks after intervention
Change in Nine-Hole-Peg test, follow up 2	Expressed in pegs/second. Higher values indicate better outcome. Assessed by qualified physical or occupational therapists.	Difference between the week before intervention and 12 weeks after stroke onset
Change in action research arm test (ARAT) score, after intervention	Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before the intervention and the week after intervention
Change in action research arm test (ARAT) score, follow up 1	Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 4 weeks after intervention
Change in action research arm test (ARAT) score, follow up 2	Scale range 0-57 points, higher values indicate better outcome. Assessed by qualified physical or occupational therapists	Difference between the week before intervention and 12 weeks after stroke onset
Change in Functional Independence Measure (FIM) score, after intervention	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before the intervention and the week after intervention
Change in Functional Independence Measure (FIM) score, follow up 1	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before intervention and 4 weeks after intervention
Change in Functional Independence Measure (FIM) score, follow up 2	Range 18-126, higher values indicate better outcome. Assessed by rehabilitation nurses.	Difference between the week before intervention and 12 weeks after stroke onset

Collaborators and Investigators

• Sponsor: Adrian Guggisberg
• Collaborators: University Hospital, Geneva; Ecole Polytechnique Fédérale de Lausanne; Clinique Romande de Readaptation
• Investigators: Principal Investigator: Adrian G Guggisberg, MD, University of Geneva; Study Director: José Millán, PhD, Ecole Polytechnique Fédérale de Lausanne

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: CRSII5-170985A

Drug and device information, study documents

• 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