Manual Dexterity Control After Cerebellar Stimulation

Stroke Clinical Trial

— MADECCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03092570
• Other study ID #: D16-P03
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: October 18, 2017
• Start date: June 12, 2017
• Est. completion date: June 2019

Study information

• Verified date: October 2017
• Source: Centre Hospitalier St Anne
• Contact: Marion Verneau, PhD
• Phone: +33140788663
• Email: mverneau[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• No stimulation
ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.

Locations

Country	Name	City	State
France	Centre de Recherche Clinique (CRC) - CHSA	Paris
France	Service de Médecine Physique et Rédaptation	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Force control	Measurement in Newton of the force applied by each finger.	Day 1
Primary	Force control	Measurement in Newton of the force applied by each finger.	Day 2
Primary	Force control	Measurement in Newton of the force applied by each finger.	Day 3
Primary	Force control	Measurement in Newton of the force applied by each finger.	Day 10
Primary	Overflow	Measurement in ms of the involuntary finger movements.	Day 1
Primary	Overflow	Measurement in ms of the involuntary finger movements.	Day 2
Primary	Overflow	Measurement in ms of the involuntary finger movements.	Day 3
Primary	Overflow	Measurement in ms of the involuntary finger movements.	Day 10
Secondary	Moberg Pick-up Test	Assessment of the functionality of the hand. One score will be given at the end of the test.	Day 1
Secondary	Moberg Pick-up Test	Assessment of the functionality of the hand. One score will be given at the end of the test.	Day 2
Secondary	Moberg Pick-up Test	Assessment of the functionality of the hand. One score will be given at the end of the test.	Day 3
Secondary	Moberg Pick-up Test	Assessment of the functionality of the hand. One score will be given at the end of the test.	Day 10
Secondary	Action Research Arm Test	Assessment of the upper limb mobility. One score will be given at the end of the test	Day 1
Secondary	Action Research Arm Test	Assessment of the upper limb mobility. One score will be given at the end of the test	Day 2
Secondary	Action Research Arm Test	Assessment of the upper limb mobility. One score will be given at the end of the test	Day 3
Secondary	Action Research Arm Test	Assessment of the upper limb mobility. One score will be given at the end of the test	Day 10
Secondary	Finger time release	Time needed to release the finger force when needed (in ms).	Day 1
Secondary	Finger time release	Time needed to release the finger force when needed (in ms).	Day 2
Secondary	Finger time release	Time needed to release the finger force when needed (in ms).	Day 3
Secondary	Finger time release	Time needed to release the finger force when needed (in ms).	Day 10