Neurophysiological Study of tDCS Effects in Healthy Volunteers (tDCSHV)

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Cefaly tDCS

Detailed Description

Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine.

The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Liége, Belgium, 4000
    • Roberta Baschi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cefaly tDCS; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological mesures changes	Modifications in neurophysiological test after direct current stimulation	up to 1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VEP changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month
Blink changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month
CHEPS changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month
Quantitave Sensory Testing	Evaluation of changes in thresholds	up to 1 month

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Principal Investigator: Delphine Magis, MD, University of Liege; Principal Investigator: Jean Schoenen, MD, University of Liege

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 27, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CB-1200