NCT02956304

Brief Summary

The purpose of this study is determine the involvement of motor system in the memory of manipulable objects. The idea is to stimulate the ventral premotor cortex with transcranial magnetic stimulation to see whether this stimulation will affect memory of manipulable objects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

July 20, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 3, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 28, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

July 20, 2016

Last Update Submit

April 26, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • Number of objects affordants and of objects not - affordants reminded

    Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control

    1 week

  • Number of objects affordants and of objects not - affordants reminded

    Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control

    2 weeks

  • Number of objects affordants and of objects not - affordants reminded

    Measure of the number of objects affordants and of objects not - affordants reminded according to if the stimulation is in PMv or control

    3 weeks

Secondary Outcomes (3)

  • Number of object reminded

    1 week

  • Number of object reminded

    2 weeks

  • Number of object reminded

    3 weeks

Study Arms (6)

Group iTBS-cTBS-SHAM

OTHER

PMv stimulation (iTBS) at session 2, PMv inhibition (cTBS) at session 3, and control (SHAM) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Group iTBS-SHAM-cTBS

OTHER

PMv stimulation (iTBS) at session 2, control (SHAM) at session 3, and PMv inhibition (cTBS) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Group cTBS-iTBS-SHAM

OTHER

PMv inhibition (cTBS) at session 2, PMv stimulation (iTBS) at session 3, and control (SHAM) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Group cTBS-SHAM-iTBS

OTHER

PMv inhibition (cTBS) at session 2, control (SHAM) at session 3, and PMv stimulation (iTBS) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Group SHAM-iTBS-cTBS

OTHER

control (SHAM) at session 2, PMv stimulation (iTBS) at session 3, and PMv inhibition (cTBS) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Group SHAM-cTBS-iTBS

OTHER

control (SHAM) at session 2, PMv inhibition (cTBS) at session 3, and PMv stimulation (iTBS) at session 4

Other: PMv stimulation (iTBS)Other: PMv inhibition (cTBS)Other: Control (SHAM)

Interventions

PMv stimulation (iTBS)OTHER

PMv stimulation (iTBS)

Group SHAM-cTBS-iTBSGroup SHAM-iTBS-cTBSGroup cTBS-SHAM-iTBSGroup cTBS-iTBS-SHAMGroup iTBS-SHAM-cTBSGroup iTBS-cTBS-SHAM
PMv inhibition (cTBS)OTHER

PMv inhibition (cTBS)

Group SHAM-cTBS-iTBSGroup SHAM-iTBS-cTBSGroup cTBS-SHAM-iTBSGroup cTBS-iTBS-SHAMGroup iTBS-SHAM-cTBSGroup iTBS-cTBS-SHAM
Control (SHAM)OTHER

Control (SHAM)

Group SHAM-cTBS-iTBSGroup SHAM-iTBS-cTBSGroup cTBS-SHAM-iTBSGroup cTBS-iTBS-SHAMGroup iTBS-SHAM-cTBSGroup iTBS-cTBS-SHAM

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • and 35 years
  • Right-handers (score between 70 and 100 on the scale of Edinburgh)
  • Native language : French
  • Not depressed (score lower than 14 in the BDI)
  • health insurance
  • Consent

You may not qualify if:

  • Psychiatric family history up to the second degree
  • Medical treatment, in particular psychotropic being able to affect the memory and the attention
  • view or hearing disorders (not compensated)
  • neurological histories (epilepsy, alcoholism in particular) or psychiatric or important memory complaints
  • Contraindications for the SMT
  • contraindications in the MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche Clinique (CRC) - CHSA

Paris, 75014, France

RECRUITING

MeSH Terms

Interventions

salicylhydroxamic acid

Study Officials

  • Pascale PIOLINO

    University of Paris 5 - Rene Descartes

    STUDY DIRECTOR

  • Benoit CREPON, MD

    CHSA

    STUDY DIRECTOR

Central Study Contacts

Benoit CREPON, MD

CONTACT

00 33 1 45 65 87 70b.crepon@ch-sainte-anne.fr

Marie GODARD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2016

First Posted

November 7, 2016

Study Start

April 3, 2017

Primary Completion

July 1, 2018

Study Completion

November 1, 2018

Last Updated

April 28, 2017

Record last verified: 2017-04

Locations

FR(1)