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MI Practice and tDCS With Aging (MISt)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813291
Recruitment Status : Completed
First Posted : June 24, 2016
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Aging Motor Learning Device: tDCS Device: sham tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Effects of Motor Imagery Practice Combined With Transcranial Direct Current Stimulation in the Learning of a Complex Motor Sequence in Young and Elderly Subjects
Actual Study Start Date : April 26, 2017
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : March 22, 2019

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.





Primary Outcome Measures :
  1. Change in the number of correct sequences between first pretest and retention test [ Time Frame: 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 :
  1. Change in the number of correct sequences between first pretest and third posttest [ Time Frame: 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

  2. Change in the power of the Mu rhythm between first pretest and retention test [ Time Frame: 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

  3. Change in the power of the Mu rhythm between first pretest and third posttest [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813291


Locations
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France
Hospices Civils de Lyon - Hôpital des Charpennes - 27, rue Gabriel Péri
Villeurbanne, France, 69100
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre Krolak-Salmon, Pr, PU-PH Hospices Civils de Lyon - Hôpital des Charpennes
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02813291    
Other Study ID Numbers: 69HCL15_0719
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Motor imagery
transcranial direct current stimulation
motor learning
aging