Manual Dexterity Control After Cerebellar Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: With stimulation
* Device: No stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS Post-CVA<br>The participants will get a 20min stimulation at a maximal intensity of 2mA | Device: With stimulation<br>* ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions<br>|
| Sham Comparator: Sham Post-CVA<br>The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task | Device: No stimulation<br>* ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.<br>|
| Experimental: tDCS Young Healthy<br>The participants will get a 20min stimulation at a maximal intensity of 2mA | Device: With stimulation<br>* ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions<br>|
| Sham Comparator: Sham Young Healthy<br>The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task | Device: No stimulation<br>* ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.<br>|
| Experimental: tDCS Older Healthy<br>The participants will get a 20min stimulation at a maximal intensity of 2mA | Device: With stimulation<br>* ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions<br>|
| Sham Comparator: Sham Older Healthy<br>The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task | Device: No stimulation<br>* ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force control | Measurement in Newton of the force applied by each finger. | Day 1 | 
| Force control | Measurement in Newton of the force applied by each finger. | Day 2 | 
| Force control | Measurement in Newton of the force applied by each finger. | Day 3 | 
| Force control | Measurement in Newton of the force applied by each finger. | Day 10 | 
| Overflow | Measurement in ms of the involuntary finger movements. | Day 1 | 
| Overflow | Measurement in ms of the involuntary finger movements. | Day 2 | 
| Overflow | Measurement in ms of the involuntary finger movements. | Day 3 | 
| Overflow | Measurement in ms of the involuntary finger movements. | Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moberg Pick-up Test | Assessment of the functionality of the hand. One score will be given at the end of the test. | Day 1 | 
| Moberg Pick-up Test | Assessment of the functionality of the hand. One score will be given at the end of the test. | Day 2 | 
| Moberg Pick-up Test | Assessment of the functionality of the hand. One score will be given at the end of the test. | Day 3 | 
| Moberg Pick-up Test | Assessment of the functionality of the hand. One score will be given at the end of the test. | Day 10 | 
| Action Research Arm Test | Assessment of the upper limb mobility. One score will be given at the end of the test | Day 1 | 
| Action Research Arm Test | Assessment of the upper limb mobility. One score will be given at the end of the test | Day 2 | 
| Action Research Arm Test | Assessment of the upper limb mobility. One score will be given at the end of the test | Day 3 | 
| Action Research Arm Test | Assessment of the upper limb mobility. One score will be given at the end of the test | Day 10 | 
| Finger time release | Time needed to release the finger force when needed (in ms). | Day 1 | 
| Finger time release | Time needed to release the finger force when needed (in ms). | Day 2 | 
| Finger time release | Time needed to release the finger force when needed (in ms). | Day 3 | 
| Finger time release | Time needed to release the finger force when needed (in ms). | Day 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motor learning, stroke, tDCS, upper limb