Manual Dexterity Control After Cerebellar Stimulation

Not Applicable

• Conditions: Stroke
• Interventions: Device: With stimulation; Device: No stimulation

• Registration Number: NCT03092570
• Lead Sponsor: Centre Hospitalier St Anne

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.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-03-22
• Study First Posted: 2017-03-28
• Study Start: 2017-06-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-10-19
• Primary Completion: 2019-04
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS Older Healthy	With stimulation	The participants will get a 20min stimulation at a maximal intensity of 2mA
tDCS Post-CVA	With stimulation	The participants will get a 20min stimulation at a maximal intensity of 2mA
Sham Young Healthy	No stimulation	The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
Sham Post-CVA	No stimulation	The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
Sham Older Healthy	No stimulation	The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
tDCS Young Healthy	With stimulation	The participants will get a 20min stimulation at a maximal intensity of 2mA

Primary Outcome Measures

Name	Time	Method
Force control	Day 10	Measurement in Newton of the force applied by each finger.
Overflow	Day 10	Measurement in ms of the involuntary finger movements.

Secondary Outcome Measures

Name	Time	Method
Finger time release	Day 10	Time needed to release the finger force when needed (in ms).
Action Research Arm Test	Day 10	Assessment of the upper limb mobility. One score will be given at the end of the test
Moberg Pick-up Test	Day 10	Assessment of the functionality of the hand. One score will be given at the end of the test.

Trial Locations

Locations (2)

Centre de Recherche Clinique (CRC) - CHSA; 🇫🇷 Paris, France

Service de Médecine Physique et Rédaptation; 🇫🇷 Paris, France