Manual Dexterity Control After Cerebellar Stimulation (MADECCS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: With stimulation; Device: No stimulation

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Centre de Recherche Clinique (CRC) - CHSA
    • Contact: Cecile Bergot; Phone Number: 00 33 1 45 65 84 90; Email: c.bergot@ch-sainte-anne.fr
    • Principal Investigator: Macarena CUENCA
    • Contact: Macarena CUENCA, MD; Email: m.cuenca@ch-sainte-anne.fr
  • Paris, France, 75014
    • Not yet recruiting
    • Service de Médecine Physique et Rédaptation
    • Contact: Marie GODARD; Phone Number: 00 33 1 45 65 77 28; Email: marie.godard@aphp.fr
    • Contact: Florence COLLE, MD; Phone Number: 00331 45 65 62 00; Email: f.colle@ch-sainte-anne.fr
    • Principal Investigator: Florence COLLE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Principal Investigator: Florence COLLE, MD, CHSA

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2017
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: tDCS; stroke; upper limb; Motor learning
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: D16-P03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No