MI Practice and tDCS With Aging

Not Applicable

Completed

• Conditions: Aging; Motor Learning
• Interventions: Device: sham tDCS; Device: tDCS

• Registration Number: NCT02813291
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The mental repetition of movements - or motor imagery (MI) practice - facilitates motor learning. It allows avoiding fatigue that occurs during physical practice; this method is thus particularly interesting for elderly people. Transcranial direct current stimulation (tDCS) is a noninvasive method of neurostimulation during which a low direct current is applied to the brain via electrodes placed on the scalp. This method has been successfully used to enhance motor learning in both young and elderly subjects.

The main aim of this study is to assess the impact of MI practice combined with tDCS on the learning of a complex finger sequence, in young and elderly subjects.

For that purpose, young and elderly healthy subjects will be randomly assigned to Stimulation and Sham groups. There will thus be a total of four groups: Young Stim, Young Sham, Elderly Stim, and Elderly Sham.

All subjects will participate to three training sessions spread over five days, and a retention test one week after the third training session.

During training they will mentally repeat a complex finger sequence with the left hand, for 13 min:

* Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.

* Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

Immediately before (pretest) and after (posttest) each training session, as well as during the retention test, subjects will repeat the sequence as many times of possible, for 1 min. During these tests (pretests, posttests and retention test) electroencephalographic activity will be recorded to assess the Mu rhythm power.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Study Start: 2017-04-26
• Primary Completion: 2019-03-22
• Study Completion: 2019-03-22
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Being aged between 20 and 35 years for the young subjects / between 65 and 80 years for the elderly subjects
• For elderly subjects: Mini Mental State Examination (MMSE) ≥ 24
• Being a male or a female
• Being right handed
• Taking an effective method of contraception for the women of childbearing age
• Having signed the consent form
• Being registered with a social security scheme

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Exclusion Criteria

• Presenting a neurologic, psychiatric or motor trouble

• Practicing or having practiced at least 5 hours by week an activity involving a high manual dexterity (e.g. piano)

• Showing any contraindication to tDCS:

  • History of epilepsy
  • head trauma with loss of consciousness
  • Implanted material (pacemaker, surgical clips, metal specks in the skull, etc.)
  • Past neurosurgical intervention
  • Open sore on the scalp
  • Consumption of more than three glasses of alcohol daily
  • Use of drugs
  • Pregnancy (positive pregnancy test)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group (Young Sham)	sham tDCS	Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.
Stimulation group (Elderly Stim)	tDCS	Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.
Sham group (Elderly Sham)	sham tDCS	Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.
Stimulation group (Young Stim)	tDCS	Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.

Primary Outcome Measures

Name	Time	Method
Change in the number of correct sequences between first pretest and retention test	The number of correct sequences will be assessed at pretest of the first training session (day 1) and at retention test (day 10).	Change will be calculated using the following formulae: (number of correct sequences at retention test - number of correct sequences at first pretest) / number of correct sequences at first pretest × 100

Secondary Outcome Measures

Name	Time	Method
Change in the power of the Mu rhythm between first pretest and third posttest	The power of the Mu rhythm will be assessed at pretest of the first training session (day 1) and at posttest of the third session (day 3)	Change will be calculated using the following formulae: (power of the Mu rhythm at third posttest - power of the Mu rhythm at first pretest) / power of the Mu rhythm at first pretest × 100
Change in the power of the Mu rhythm between first pretest and retention test	The power of the Mu rhythm will be assessed at pretest of the first training session (day 1) and at retention test (day 10)	Change will be calculated using the following formulae: (power of the Mu rhythm at retention test - power of the Mu rhythm at first pretest) / power of the Mu rhythm at first pretest × 100
Change in the number of correct sequences between first pretest and third posttest	The number of correct sequences will be assessed at pretest of the first training session (day 1) and at posttest of the third training session (day 3)	Change will be calculated using the following formulae: (number of correct sequences at third posttest - number of correct sequences at first pretest) / number of correct sequences at first pretest × 100

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hôpital des Charpennes - 27, rue Gabriel Péri; 🇫🇷 Villeurbanne, France