Manual Dexterity Control After Cerebellar Stimulation (MADECCS)

Centre Hospitalier St Anne

Status: Unknown

Conditions: Stroke

Treatments: Device: No stimulation; Device: With stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03092570

D16-P03

Details and patient eligibility

About

This study will assess the putative advantages of cerebellar stimulation on motor learning abilities of stroke patients. In order to have a control group to refer to, the effect of cerebellar stimulation on healthy young and old participants will also be assessed.

Full description

Cerebrovascular accidents (CVA) are the first cause of acquired disability in France. Despite rehabilitation interventions, a great proportion of patients suffers from motor disability in the upper limb. Recently, several studies have shown that post CVA patients exhibit great neural plasticity as a direct consequence of their condition.

Interestingly, the transcranial direct current stimulation (tDCS) is a non-invasive electro stimulation technique that allows for a modulation of cerebral activity. It has been shown that when applied to the cerebellum, tDCS increases learning performances of healthy subjects. Yet, motor rehabilitation after a CVA highly relies on motor (re)learning. The cerebellar tDCS thus appear as a promising method to enhance the performance of post-CVA motor learning and consequently the benefits of post-CVA rehabilitation.

The current study aims to promote the post CVA neural plasticity by using the tDCS in order to enhance motor learning of the upper limb.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Right-handed
• Affiliated to the French health insurance or similar organisation
• Signed informed consent
• Clinical examination

For "Post-AVC patients" :

• at least 18 years old
• completed the Moberg Pick-up test with a minimum score of 20 secondes For "Young healthy" group
• 18 = or > years = or <30 For "Older healthy" group
• 50 > or = years = or < 80

Exclusion criteria

• Metallic implant in the head
• Pacemaker, or other electronic implanted devices
• Other central neurological disease
• Pregnancy, breast feeding
• Previous history of neurosurgery or seizures or 1st degree relative with history of seizures
• History of medical neurological or psychiatric disorders
• Participation to another study using cerebral stimulation
• History of bi-polar or recurring depressive disorders
• Planned carotid revascularization, severe caridac disease
• Kidney failure (transaminase > 2 times normal value)
• Other invalidating condition or deficiency interfering with the study

For "Post-AVC patients" :

• NIHSS score > 20
• Cerebellar ischemic CVA

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 6 patient groups

tDCS Post-CVA

Experimental group

Description:

The participants will get a 20min stimulation at a maximal intensity of 2mA

Treatment:

Device: With stimulation

Sham Post-CVA

Sham Comparator group

Description:

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

Treatment:

Device: No stimulation

tDCS Young Healthy

Experimental group

Description:

The participants will get a 20min stimulation at a maximal intensity of 2mA

Treatment:

Device: With stimulation

Sham Young Healthy

Sham Comparator group

Description:

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

Treatment:

Device: No stimulation

tDCS Older Healthy

Experimental group

Description:

The participants will get a 20min stimulation at a maximal intensity of 2mA

Treatment:

Device: With stimulation

Sham Older Healthy

Sham Comparator group

Description:

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

Treatment:

Device: No stimulation