MI Practice and tDCS With Aging (MISt)

Effects of Motor Imagery Practice Combined With Transcranial Direct Current Stimulation in the Learning of a Complex Motor Sequence in Young and Elderly Subjects

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.

Study Overview

• Status: Completed
• Conditions: Aging; Motor Learning
• Intervention / Treatment: Device: tDCS; Device: sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Villeurbanne, France, 69100
    • Hospices Civils de Lyon - Hôpital des Charpennes - 27, rue Gabriel Péri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stimulation group (Young Stim); Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.	Device: tDCS; All subjects 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.
Experimental: Stimulation group (Elderly Stim); Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex.	Device: tDCS; All subjects 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.
Sham Comparator: Sham group (Young Sham); Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.	Device: sham tDCS; All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min: - Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.
Sham Comparator: Sham group (Elderly Sham); Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.	Device: sham tDCS; All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min: - Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of correct sequences between first pretest and retention test	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	The number of correct sequences will be assessed at pretest of the first training session (day 1) and at retention test (day 10).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of correct sequences between first pretest and third posttest	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	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 in the power of the Mu rhythm between first pretest and retention test	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	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 in the power of the Mu rhythm between first pretest and third posttest	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	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)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pierre Krolak-Salmon, Pr, PU-PH, Hospices Civils de Lyon - Hôpital des Charpennes

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2017
• Primary Completion (Actual): March 22, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): April 8, 2019
• Last Update Submitted That Met QC Criteria: April 5, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; aging; motor learning; Motor imagery
• Other Study ID Numbers: 69HCL15_0719

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No