NCT02125422

Brief Summary

Transcranial direct current stimulation is a tool to modulate cortical excitability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Nov 2013

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

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 29, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1 month

First QC Date

April 18, 2014

Last Update Submit

May 27, 2015

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Neurophysiological mesures changes

    Modifications in neurophysiological test after direct current stimulation

    up to 1 month

Other Outcomes (4)

  • VEP changes

    up to 1 month

  • Blink changes

    up to 1 month

  • CHEPS changes

    up to 1 month

  • +1 more other outcomes

Study Arms (1)

Cefaly tDCS

EXPERIMENTAL

Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, for 5 consecutive days in 9 HV. The anode is placed over the left DLPFC. 2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, for 5 consecutive days in 9 HV

Device: Cefaly tDCS

Interventions

Cefaly tDCSDEVICE

Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.

Cefaly tDCS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers

You may not qualify if:

  • age below 18 or above 65 years
  • personal history of recurrent headache or other neurological diseases especially seizures,
  • familial history of recurrent headache
  • child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .)
  • chronic pain syndromes
  • analgesics intake at the time of recording
  • contra-indications to tDCS neurostimulation (metal prosthetics in the head or internal stimulation like a pacemaker).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberta Baschi

Liége, Liége, 4000, Belgium

Location

Study Officials

  • Delphine Magis, MD

    University of Liege

    PRINCIPAL INVESTIGATOR

  • Jean Schoenen, MD

    University of Liege

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Full Professor

Study Record Dates

First Submitted

April 18, 2014

First Posted

April 29, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2013

Study Completion

April 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)