ADHD Electrophysiological Subtypes and Implications in Transcranial Direct-current Stimulation

NCT01649232 | Completed Results DMC

• 1 other identifier: vpradtdcs0102012
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study the aim is to examine whether transcranial direct-current stimulation (tDCS) generated excitability changes and induce modifications of functional cortical architecture in Attention Deficit Hyperactivity Disorder (ADHD) patients. To achieve this, the investigators 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/F4 or T5/T6 or P4/P3, 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.

Conditions

ADHD; ADD

Keywords

tdcs; tms; qeeg; neuroplasticity; brain networks; add; adhs

Outcome Measures

Primary Outcomes (1)

• Clinical Assessment (Amen Questionnaire)

  The Amen Attention Deficit Disorder (ADD) Type Questionnaire is a 71-question self-test that evaluates the ADD syndrome. 0 never, 1 rarely, 2 Occasionally, 3 Often and 4 Very Often. Consists of a series of questions that evaluate five brain systems: basal ganglia (23 items), Cingular System (17 items), Temporal System (16 items), Prefrontal Cortex (24 items) and deep limbic system (20 items). Each system has a maximum score of 4, and if this punctuation is greater than 1.7 it is possible that the system is deviated from normality and implicated in AD/HD behavior. The minimal average score is 5 (Best) and the maximum is 20 (Worst). More than four is suspicious of diagnosis, six or more of a score of three or four is needed to make diagnosis. Meets the criteria for inattentiveness (six or more on questions 1-14) and also scores six or more on the cingular system questions (24-36 items), over-focused ADD subtype is suspected.

  From September to December 2012

Secondary Outcomes (4)

• Event-related Potentials Amplitude (ERPs)

  From September to December 2012

• Event-related Potentials Latency (ERPs)

  From September to December 2012

• Reaction Time (Behavior Task)

  From September to December 2012

• Number of Omission and Commission Errors of Behavior Task

  From September to December 2012

Study Arms (2)

active tDCS

The patients with ADHD received electro-stimulation at 20 sessions with 2 mAmp 1 session per day alternative days. The investigators used an ERP analysis derived of 20 channel EEG recordings during resting state and visual CPT to define the tDCS site and polarity at refractory ADHD patients to conventional treatments. Time courses, topography and amplitude of ERPs, correlated with clinical scores, were compared with the controls average (data base)to guide the selection of personal tDCS parameters. The following relation shown how many patients were submitted to intervention in each electrode, according to their polarity: Anodal tDCS: T5, T6, etc. Cathodal tDCS: T5, T6, etc.

Device: Active tDCS

controls

Healthy people that not receive tDCS

Interventions

Active tDCS DEVICE

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).

Also known as: Chattanooga Iontophoresis

active tDCS

Eligibility Criteria

• Age: 8 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

ADHD children from 5 to 13 years old and controls

You may qualify if:

• ADHD diagnosis.
• Age between 7 and 65 years.

You may not qualify if:

• Presence of psychosis.
• Subjects taking medication,they had refrained from taking methylphenidate during 24 hours before testing.
• Subjects taking other psychotropics were not included in the study.
• 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.

Sponsors & Collaborators

• Spanish Foundation for Neurometrics Development: lead

Study Sites (1)

New Remedies

Liverpool, L1 0AH, United Kingdom

Location

Related Publications (4)

• Mueller A, Candrian G, Grane VA, Kropotov JD, Ponomarev VA, Baschera GM. Discriminating between ADHD adults and controls using independent ERP components and a support vector machine: a validation study. Nonlinear Biomed Phys. 2011 Jul 19;5:5. doi: 10.1186/1753-4631-5-5.

  PMID: 21771289 RESULT

• Mueller A, Candrian G, Kropotov JD, Ponomarev VA, Baschera GM. Classification of ADHD patients on the basis of independent ERP components using a machine learning system. Nonlinear Biomed Phys. 2010 Jun 3;4 Suppl 1(Suppl 1):S1. doi: 10.1186/1753-4631-4-S1-S1.

  PMID: 20522259 RESULT

• Bledsoe JC, Xiao C, Chaovalitwongse A, Mehta S, Grabowski TJ, Semrud-Clikeman M, Pliszka S, Breiger D. Diagnostic Classification of ADHD Versus Control: Support Vector Machine Classification Using Brief Neuropsychological Assessment. J Atten Disord. 2020 Sep;24(11):1547-1556. doi: 10.1177/1087054716649666. Epub 2016 May 26.

  PMID: 27231214 RESULT

• Mikolas P, Vahid A, Bernardoni F, Suss M, Martini J, Beste C, Bluschke A. Training a machine learning classifier to identify ADHD based on real-world clinical data from medical records. Sci Rep. 2022 Jul 28;12(1):12934. doi: 10.1038/s41598-022-17126-x.

  PMID: 35902654 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Moises Aguilar-Domingo, Chairman of Spanish Neurometrics Foundation
• Organization: Spanish Neurometrics Foundation

moises.aguilar@gmail.com

+34 634548720

Study Officials

• Moises Aguilar Domingo, PhD

  Brainmech Foundation

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: July 25, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 9, 2024
• Results First Posted: April 21, 2014

Record last verified: 2024-05

Locations

GB (1)