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Manual Dexterity Control After Cerebellar Stimulation (MADECCS)

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
With stimulation
No stimulation
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Motor learning, stroke, tDCS, upper limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Recherche Clinique (CRC) - CHSARecruiting
  • Service de Médecine Physique et Rédaptation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Sham Comparator

Experimental

Sham Comparator

Experimental

Sham Comparator

Arm Label

tDCS Post-CVA

Sham Post-CVA

tDCS Young Healthy

Sham Young Healthy

tDCS Older Healthy

Sham Older Healthy

Arm Description

The participants will get a 20min stimulation at a maximal intensity of 2mA

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

The participants will get a 20min stimulation at a maximal intensity of 2mA

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

The participants will get a 20min stimulation at a maximal intensity of 2mA

The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task

Outcomes

Primary Outcome Measures

Force control
Measurement in Newton of the force applied by each finger.
Force control
Measurement in Newton of the force applied by each finger.
Force control
Measurement in Newton of the force applied by each finger.
Force control
Measurement in Newton of the force applied by each finger.
Overflow
Measurement in ms of the involuntary finger movements.
Overflow
Measurement in ms of the involuntary finger movements.
Overflow
Measurement in ms of the involuntary finger movements.
Overflow
Measurement in ms of the involuntary finger movements.

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2017
Last Updated
October 18, 2017
Sponsor
Centre Hospitalier St Anne
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1. Study Identification

Unique Protocol Identification Number
NCT03092570
Brief Title
Manual Dexterity Control After Cerebellar Stimulation
Acronym
MADECCS
Official Title
Assessment of Cerebellar Stimulation Effect on Motor Learning in Ageing Population and Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Motor learning, stroke, tDCS, upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS Post-CVA
Arm Type
Experimental
Arm Description
The participants will get a 20min stimulation at a maximal intensity of 2mA
Arm Title
Sham Post-CVA
Arm Type
Sham Comparator
Arm Description
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
Arm Title
tDCS Young Healthy
Arm Type
Experimental
Arm Description
The participants will get a 20min stimulation at a maximal intensity of 2mA
Arm Title
Sham Young Healthy
Arm Type
Sham Comparator
Arm Description
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
Arm Title
tDCS Older Healthy
Arm Type
Experimental
Arm Description
The participants will get a 20min stimulation at a maximal intensity of 2mA
Arm Title
Sham Older Healthy
Arm Type
Sham Comparator
Arm Description
The tDCS will be placed as for the Experimental group and will last 30 seconds at the beginning of task
Intervention Type
Device
Intervention Name(s)
With stimulation
Intervention Description
ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions
Intervention Type
Device
Intervention Name(s)
No stimulation
Intervention Description
ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.
Primary Outcome Measure Information:
Title
Force control
Description
Measurement in Newton of the force applied by each finger.
Time Frame
Day 1
Title
Force control
Description
Measurement in Newton of the force applied by each finger.
Time Frame
Day 2
Title
Force control
Description
Measurement in Newton of the force applied by each finger.
Time Frame
Day 3
Title
Force control
Description
Measurement in Newton of the force applied by each finger.
Time Frame
Day 10
Title
Overflow
Description
Measurement in ms of the involuntary finger movements.
Time Frame
Day 1
Title
Overflow
Description
Measurement in ms of the involuntary finger movements.
Time Frame
Day 2
Title
Overflow
Description
Measurement in ms of the involuntary finger movements.
Time Frame
Day 3
Title
Overflow
Description
Measurement in ms of the involuntary finger movements.
Time Frame
Day 10
Secondary Outcome Measure Information:
Title
Moberg Pick-up Test
Description
Assessment of the functionality of the hand. One score will be given at the end of the test.
Time Frame
Day 1
Title
Moberg Pick-up Test
Description
Assessment of the functionality of the hand. One score will be given at the end of the test.
Time Frame
Day 2
Title
Moberg Pick-up Test
Description
Assessment of the functionality of the hand. One score will be given at the end of the test.
Time Frame
Day 3
Title
Moberg Pick-up Test
Description
Assessment of the functionality of the hand. One score will be given at the end of the test.
Time Frame
Day 10
Title
Action Research Arm Test
Description
Assessment of the upper limb mobility. One score will be given at the end of the test
Time Frame
Day 1
Title
Action Research Arm Test
Description
Assessment of the upper limb mobility. One score will be given at the end of the test
Time Frame
Day 2
Title
Action Research Arm Test
Description
Assessment of the upper limb mobility. One score will be given at the end of the test
Time Frame
Day 3
Title
Action Research Arm Test
Description
Assessment of the upper limb mobility. One score will be given at the end of the test
Time Frame
Day 10
Title
Finger time release
Description
Time needed to release the finger force when needed (in ms).
Time Frame
Day 1
Title
Finger time release
Description
Time needed to release the finger force when needed (in ms).
Time Frame
Day 2
Title
Finger time release
Description
Time needed to release the finger force when needed (in ms).
Time Frame
Day 3
Title
Finger time release
Description
Time needed to release the finger force when needed (in ms).
Time Frame
Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Verneau, PhD
Phone
+33140788663
Email
mverneau@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marie GODARD
Phone
00 33 1 45 65 77 28
Email
marie.godard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence COLLE, MD
Organizational Affiliation
CHSA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Recherche Clinique (CRC) - CHSA
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Macarena CUENCA, MD
Email
m.cuenca@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Cecile Bergot
Phone
00 33 1 45 65 84 90
Email
c.bergot@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Macarena CUENCA
Facility Name
Service de Médecine Physique et Rédaptation
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florence COLLE, MD
Phone
00331 45 65 62 00
Email
f.colle@ch-sainte-anne.fr
First Name & Middle Initial & Last Name & Degree
Marie GODARD
Phone
00 33 1 45 65 77 28
Email
marie.godard@aphp.fr
First Name & Middle Initial & Last Name & Degree
Florence COLLE, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Manual Dexterity Control After Cerebellar Stimulation

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