ADHD Electrophysiological Subtypes and Implications in Transcranial Direct-current Stimulation (tdcs&adhd)

This study is currently recruiting participants.
Verified July 2012 by Spanish Foundation for Neurometrics Development
Sponsor:
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT01649232
First received: June 18, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

In the present study, we aim to examine whether transcranial direct-current stimulation (tDCS) generated excitability changes induce modifications of functional cortical architecture in Attention Deficit Hyperactivity Disorder (ADHD) patients. To achieve this, we used an event-related potential (ERP) analysis based on 20 channel EEG recordings in ADHD subjects before and after bipolar tDCS-anode stimulation over F3, during resting state and measure clinical scores and visual CPT tasks changes. Time courses and topography of independent component visual ERPs were compared before and after tDCS.


Condition Intervention Phase
ADHD
ADD
Device: Transcranial Direct-Current Stimulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implications of Electrophysiological ADHD Endophenotypes to Predict Response to Transcranial Direct-Current Stimulation

Further study details as provided by Spanish Foundation for Neurometrics Development:

Primary Outcome Measures:
  • Observable behaviour [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The primary outcome was change in score on the QEEG Rating Scale (AMEN questionnaire), which assesses behaviour. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation.


Secondary Outcome Measures:
  • Event-related potentials (ERPs) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    ERPs to the GO/NOGO task will be examined for changes as a result of treatment. Assessments were made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation.


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active tDCS in DLPFC
Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
Device: Transcranial Direct-Current Stimulation
tDCS applied to left dorsolateral prefrontal scalp area through a saline-soaked pair of surface sponge electrodes (35 cm2). The anode electrode was placed over F3 (based on the 10-20 International EEG System) of each subject. The cathode was placed over the contralateral mastoid area. A constant current of 1.1 mA was applied for 25 min/day (administered for 12 alternated days).
Other Name: Chattanooga Iontophresis
No Intervention: controls
Healthy people that not receive tDCS

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. ADHD diagnosis.
  2. Age between 7 and 65 years.
  3. Comorbidities were no reason for subject exclusion.

Exclusion criteria:

  1. Presence of psychosis.
  2. Subjects taking medication,they had refrained from taking methylphenidate during 24 hours before testing.
  3. Subjects taking other psychotropics were not included in the study.
  4. Subjects which had suffered of a head injury with subsequent loss of consciousness, and subjects suffering from neurological or systemic medical diseases were excluded from the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01649232

Contacts
Contact: Moises Aguilar Domingo 34634541729 moises.aguilar@gmail.com

Locations
Spain
Murcia Psychology School Recruiting
Murcia, Spain, 30100
Contact: Moises Aguilar    34634541729    moises.aguilar@gmail.com   
Principal Investigator: Moises Aguilar Domingo         
Sponsors and Collaborators
Spanish Foundation for Neurometrics Development
Investigators
Study Chair: Moises Aguilar Domingo Brainmech Foundation
  More Information

No publications provided

Responsible Party: Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier: NCT01649232     History of Changes
Obsolete Identifiers: NCT01755793
Other Study ID Numbers: vpradtdcs0102012
Study First Received: June 18, 2012
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Spanish Foundation for Neurometrics Development:
tdcs
tms
qeeg
neuroplasticity
brain networks
add
adhs

ClinicalTrials.gov processed this record on April 15, 2014