Effect of tDCS on Brain Organization and Motor Recovery

NCT ID: NCT03342534

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-13
• Study Completion Date: 2024-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

DC-stimulator (Neuroconn, Germany)

Intervention Type: DEVICE

A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.

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.

Group Type: ACTIVE_COMPARATOR

DC-stimulator (Neuroconn, Germany)

Intervention Type: DEVICE

A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.

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.

Group Type: ACTIVE_COMPARATOR

DC-stimulator (Neuroconn, Germany)

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

DC-stimulator (Neuroconn, Germany)

Intervention Type: DEVICE

A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Clinique Romande de Readaptation

NETWORK

Sponsor Role: collaborator

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: collaborator

Adrian Guggisberg

OTHER

Sponsor Role: lead

Responsible Party

Adrian Guggisberg

Médecin adjoint agrégé, assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Adrian G Guggisberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

José Millán, PhD

Role: STUDY_DIRECTOR

University of Texas - Austin

Locations

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, Switzerland

Universitäre Neurorehabilitation, Inselspital

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

CRSII5-170985A

Identifier Type: -

Identifier Source: org_study_id