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

June 6, 2025 updated by: Adrian Guggisberg

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • Universitäre Neurorehabilitation, Inselspital
    • GE
      • Geneva, GE, Switzerland, 1211
        • Division of Neurorehabilitation, University Hospital of Geneva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in upper extremity Fugl-Meyer score, after intervention
Time Frame: Difference between the week before the intervention and the week 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in EEG functional connectivity, after intervention
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before the intervention and the week 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in upper extremity Fugl-Meyer score, follow up 1
Time Frame: Difference between the week before intervention and 4 weeks after intervention
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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 4 weeks after intervention
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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 4 weeks after intervention
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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 4 weeks after intervention
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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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
Time Frame: Difference between the week before the intervention and the week 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
Time Frame: Difference between the week before intervention and 4 weeks after intervention
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
Time Frame: Difference between the week before intervention and 12 weeks after stroke onset
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Adrian Guggisberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
Ecole Polytechnique Fédérale de Lausanne
Clinique Romande de Readaptation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian G Guggisberg, MD, University of Geneva
  • Study Director: José Millán, PhD, University of Texas - Austin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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