Manual Dexterity Control After Cerebellar Stimulation

NCT03092570 | Unknown

• 1 other identifier: D16-P03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

Motor learning; stroke; tDCS; upper limb

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (12)

• Moberg Pick-up Test

  Day 1

• Moberg Pick-up Test

  Day 2

• Moberg Pick-up Test

  Day 3

• Moberg Pick-up Test

  Day 10

• Action Research Arm Test

  Day 1

Study Arms (6)

tDCS Post-CVA

EXPERIMENTAL

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

Device: With stimulation

Sham Post-CVA

SHAM COMPARATOR

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

Device: No stimulation

tDCS Young Healthy

EXPERIMENTAL

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

Device: With stimulation

Sham Young Healthy

SHAM COMPARATOR

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

Device: No stimulation

tDCS Older Healthy

EXPERIMENTAL

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

Device: With stimulation

Sham Older Healthy

SHAM COMPARATOR

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

Device: No stimulation

Interventions

With stimulation DEVICE

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

tDCS Older Healthy; tDCS Post-CVA; tDCS Young Healthy

No stimulation DEVICE

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

Sham Older Healthy; Sham Post-CVA; Sham Young Healthy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• = or \> years = or \<30 For "Older healthy" group
• \> or = years = or \< 80

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (2)

Centre de Recherche Clinique (CRC) - CHSA

Paris, 75014, France

RECRUITING

Service de Médecine Physique et Rédaptation

Paris, 75014, France

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Florence COLLE, MD

  CHSA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Verneau, PhD

CONTACT

+33140788663; mverneau@gmail.com

Marie GODARD

CONTACT

00 33 1 45 65 77 28; marie.godard@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: March 28, 2017
• Study Start: June 12, 2017
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 19, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)