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

Adrian Guggisberg

Status: Terminated

Conditions: Stroke

Treatments: Device: DC-stimulator (Neuroconn, Germany)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03342534

CRSII5-170985A

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 4 patient groups

Anodal tDCS

Active Comparator group

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.

Treatment:

Device: DC-stimulator (Neuroconn, Germany)

High definition (HD) anodal tDCS

Active Comparator group

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.

Treatment:

Device: DC-stimulator (Neuroconn, Germany)

Bihemispheric tDCS

Active Comparator group

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.

Treatment:

Device: DC-stimulator (Neuroconn, Germany)

Sham tDCS

Sham Comparator group

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.

Treatment:

Device: DC-stimulator (Neuroconn, Germany)