Effect of tDCS on Brain Organization and Motor Recovery

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Device: DC-stimulator (Neuroconn, Germany)

• Registration Number: NCT03342534
• Lead Sponsor: Adrian Guggisberg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-09
• Study Start: 2017-11-13
• Study First Posted: 2017-11-17
• Primary Completion: 2024-04-30
• Study Completion: 2024-09-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anodal tDCS	DC-stimulator (Neuroconn, Germany)	The anode is placed over the primary motor cortex of the stroke affected hemisphere, the cathode over the contralesional supraorbital front of the patient.
Bihemispheric tDCS	DC-stimulator (Neuroconn, Germany)	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.
Sham tDCS	DC-stimulator (Neuroconn, Germany)	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.
High definition (HD) anodal tDCS	DC-stimulator (Neuroconn, Germany)	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.

Primary Outcome Measures

Name	Time	Method
Change in upper extremity Fugl-Meyer score, after intervention	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

Secondary Outcome Measures

Name	Time	Method
Change in EEG functional connectivity, after intervention	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.
Change in amplitude of motor evoked potentials, after intervention	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.

Trial Locations

Locations (1)

Division of Neurorehabilitation, University Hospital of Geneva; 🇨🇭 Geneva, GE, Switzerland