Clinical trial NCT03092570: Manual Dexterity Control After Cerebellar Stimulation
Official title: Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Motor learning
stroke
tDCS
upper limb
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2017-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Force control
timeFrame: Day 1
measure: Force control
timeFrame: Day 2
measure: Force control
timeFrame: Day 3
measure: Force control
timeFrame: Day 10
measure: Overflow
timeFrame: Day 1
measure: Overflow
timeFrame: Day 2
measure: Overflow
timeFrame: Day 3
measure: Overflow
timeFrame: Day 10
Secondary outcomes:
measure: Moberg Pick-up Test
timeFrame: Day 1
measure: Moberg Pick-up Test
timeFrame: Day 2
measure: Moberg Pick-up Test
timeFrame: Day 3
measure: Moberg Pick-up Test
timeFrame: Day 10
measure: Action Research Arm Test
timeFrame: Day 1
measure: Action Research Arm Test
timeFrame: Day 2
measure: Action Research Arm Test
timeFrame: Day 3
measure: Action Research Arm Test
timeFrame: Day 10
measure: Finger time release
timeFrame: Day 1
measure: Finger time release
timeFrame: Day 2
measure: Finger time release
timeFrame: Day 3
measure: Finger time release
timeFrame: Day 10
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de Recherche Clinique (CRC) - CHSA
city: Paris
country: France
facility: Service de Médecine Physique et Rédaptation
Study officials:
affiliation: CHSA
name: Florence COLLE, MD
role: PRINCIPAL_INVESTIGATOR
References: