Effect of tDCS on Brain Organization and Motor Recovery

NCT03342534 | Terminated

• 1 other identifier: CRSII5-170985A
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in EEG functional connectivity, after intervention

  Difference between the week before the intervention and the week after intervention

• Change in amplitude of motor evoked potentials, after intervention

  Difference between the week before the intervention and the week after intervention

Other Outcomes (14)

• Change in upper extremity Fugl-Meyer score, follow up 1

  Difference between the week before intervention and 4 weeks after intervention

• Change in upper extremity Fugl-Meyer score, follow up 2

  Difference between the week before intervention and 12 weeks after stroke onset

• Change in Jamar dynamometer, after intervention

  Difference between the week before the intervention and the week after intervention

Study Arms (4)

Anodal tDCS

ACTIVE COMPARATOR

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)

High definition (HD) anodal tDCS

ACTIVE COMPARATOR

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)

Bihemispheric tDCS

ACTIVE COMPARATOR

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)

Sham tDCS

SHAM COMPARATOR

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)

Interventions

DC-stimulator (Neuroconn, Germany) 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.

Anodal tDCS; Bihemispheric tDCS; High definition (HD) anodal tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adrian Guggisberg: lead
• University Hospital, Geneva: collaborator
• Clinique Romande de Readaptation: collaborator
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (2)

Division of Neurorehabilitation, University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

Location

Universitäre Neurorehabilitation, Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adrian G Guggisberg, MD

  University of Geneva

  PRINCIPAL INVESTIGATOR

• José Millán, PhD

  University of Texas at Austin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin adjoint agrégé, assistant professor

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 17, 2017
• Study Start: November 13, 2017
• Primary Completion: April 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

CH (2)