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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Foundation for Neurometrics Development
ClinicalTrials.gov Identifier:
NCT01649232
First received: June 18, 2012
Last updated: April 19, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
ADHD
ADD
Device: Active tDCS
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:
  • Clinical Assessment (Amen Questionnaire) [ Time Frame: From September to December 2012 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Event-related Potentials Amplitude (ERPs) [ Time Frame: From September to December 2012 ] [ Designated as safety issue: Yes ]
    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. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain's executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.

  • Event-related Potentials Latency (ERPs) [ Time Frame: From September to December 2012 ] [ Designated as safety issue: Yes ]
    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. Event related potentials (ERP) generated from a visual continuous performance task (VCPT) are employed to access the early stages of information processing (Mueller et al., 2011; Kropotov, 2008) and performing at a GO/NOGO paradigm may be used to study the mechanisms of the brain's executive functions (Falkenstein et al., 1995). Amplitude and latency of ERP activity recorded from a subject can be compared to normalized databases to predict a possible hyper or hypo function of cerebral circuits. These ERP were recorded on 19 separeted channels according international 10-20 system. Electrode names are derived by brain lobule which is is located below and position, e.g., Pz is Parietal on position zero (midline) and Cz is Central Midline.

  • Reaction Time (Behavior Task) [ Time Frame: From September to December 2012 ] [ Designated as safety issue: Yes ]
    All subjects performed a Visual continuous performance task (VCPT) with GO/NOGO paradigm. It consists of three types of stimuli: 1) twenty animals (A), 2) twenty images of different plant (P), 3) Twenty images of people of different professions (H) which is present with an artificial sound called "Novel" 20msec and.Thus, each pair of stimulus is presented for 100 milliseconds, at intervals of one second of duration between each block. The objective of is to press a button as quickly as possible while observing the pairs AA, situation called GO, while trying not to press when observes other types of pairs. This latency of response (reaction time) was mensured. Pairs are called GO(AA) NOGO(AP), IGNORE(PP) and NOVEL(PH + Sound). Errors by omission (lack of response in test GO) and by commission (lack of suppression in NOGO test) were be automatically counted for each subject.

  • Number of Omission and Commission Errors of Behavior Task [ Time Frame: From September to December 2012 ] [ Designated as safety issue: Yes ]
    After VCPT task, errors by Omission (lack of response in test GO) and by commission (lack of suppression in NOGO and NOVELTY test) were automatically counted for each subject.


Enrollment: 60
Study Start Date: June 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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 Iontophoresis
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01649232

Locations
Spain
Murcia University, Psychology School
Murcia, Spain, 30100
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
Results First Received: December 15, 2012
Last Updated: April 19, 2014
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 October 19, 2014