Neurophysiological Study of tDCS Effects in Healthy Volunteers

Healthy Volunteers Clinical Trial

— tDCSHV  

Official title:

Neurophysiological Study of tDCS Effects in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125422
• Other study ID #: CB-1200
• Status: Completed
• Phase: Phase 1
• First received: April 18, 2014
• Last updated: May 27, 2015
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: May 2015
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
Belgium	Roberta Baschi	Liége

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VEP changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month	Yes
Other	Blink changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month	Yes
Other	CHEPS changes	Evaluation of changes in latency, amplitude, slope and habituation	up to 1 month	Yes
Other	Quantitave Sensory Testing	Evaluation of changes in thresholds	up to 1 month	Yes
Primary	Neurophysiological mesures changes	Modifications in neurophysiological test after direct current stimulation	up to 1 month	Yes