Manual Dexterity Control After Cerebellar Stimulation

NCT ID: NCT03092570

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2019-06-30

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.

Conditions

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Stroke

Keywords

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Motor learning stroke tDCS upper limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tDCS Post-CVA

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

Group Type EXPERIMENTAL

With stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions

Sham Post-CVA

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

Group Type SHAM_COMPARATOR

No stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.

tDCS Young Healthy

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

Group Type EXPERIMENTAL

With stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions

Sham Young Healthy

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

Group Type SHAM_COMPARATOR

No stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.

tDCS Older Healthy

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

Group Type EXPERIMENTAL

With stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions

Sham Older Healthy

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

Group Type SHAM_COMPARATOR

No stimulation

Intervention Type DEVICE

ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.

Interventions

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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

Intervention Type DEVICE

No stimulation

ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier St Anne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence COLLE, MD

Role: PRINCIPAL_INVESTIGATOR

CHSA

Locations

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Centre de Recherche Clinique (CRC) - CHSA

Paris, , France

Site Status RECRUITING

Service de Médecine Physique et Rédaptation

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Marion Verneau, PhD

Role: CONTACT

Phone: +33140788663

Email: [email protected]

Marie GODARD

Role: CONTACT

Phone: 00 33 1 45 65 77 28

Email: [email protected]

Facility Contacts

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Macarena CUENCA, MD

Role: primary

Cecile Bergot

Role: backup

Florence COLLE, MD

Role: primary

Marie GODARD

Role: backup

Other Identifiers

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D16-P03

Identifier Type: -

Identifier Source: org_study_id