NCT02813291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2019

Completed
Last Updated

September 3, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

June 22, 2016

Last Update Submit

August 26, 2025

Conditions

Keywords

Motor imagerytranscranial direct current stimulationmotor learningaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 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 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)

Study Arms (4)

Stimulation group (Young Stim)

EXPERIMENTAL

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

Device: tDCS

Stimulation group (Elderly Stim)

EXPERIMENTAL

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

Device: tDCS

Sham group (Young Sham)

SHAM COMPARATOR

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

Sham group (Elderly Sham)

SHAM COMPARATOR

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

Interventions

tDCSDEVICE

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.

Stimulation group (Elderly Stim)Stimulation group (Young Stim)
sham tDCSDEVICE

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 group (Elderly Sham)Sham group (Young Sham)

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon - Hôpital des Charpennes - 27, rue Gabriel Péri

Villeurbanne, 69100, France

Location

Related Publications (2)

  • Metais A., Muller C., Breuil C., Boublay N., di Rienzo F., Guillot A., Collet C., Krolak-Salmon P., Saimpont A. (2020). P143 Effects of Anodal tDCS combined with motor imagery on motor sequence learning in older adults. Clinical Neurophysiology 131(4):e93-e94. https://doi.org/10.1016/j.clinph.2019.12.254

    BACKGROUND
  • Muller C., Breuil C., Boublay N., Metais A., di Rienzo F., Guillot A., Collet C., Krolak-Salmon P., Saimpont A. (2020). P47 Effects of motor imagery and anodal tDCS on motor sequence learning in healthy young adults. Clinical Neurophysiology 131(4):e38-e39. https://doi.org/10.1016/j.clinph.2019.12.158

    BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Pierre Krolak-Salmon, Pr, PU-PH

    Hospices Civils de Lyon - Hôpital des Charpennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 24, 2016

Study Start

April 26, 2017

Primary Completion

March 22, 2019

Study Completion

March 22, 2019

Last Updated

September 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations