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

  Hide Detailed Description

Detailed Description:

Important advances in the understanding of ADHD pathophysiology, such fMRI studies showing a focal frontotemporal loops dysfunction in brain activity, suggest that frontal brain stimulation might be helpful for the treatment of ADHD. In a recent study of Lyon's university with tDCS they concluded that tDCS is "cheaper and easier-use than transcranial magnetic stimulation (TMS) and the impact on symptomatology seems larger (impact on negative symptoms of schizophrenic patients) and longer (at least 3 months duration) than that TMS currently permits. It is possible that tDCS could in the future be used at home by patients themselves. The efficacy of tDCS depends of parameters like electrode position and current strength.

In this trial, we investigated the effects of 12 days of anodal stimulation of the left dorsolateral prefrontal cortex (DLPFC) in ten patients with ADHD (aged 8 +/- 3 years). tDCS was applied 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).

Prior to the first session, ADHD subjects were asked to complete and return a series of questionnaires, including the Conners Brief Symptom Inventory, a health history questionnaire, and the QEEG questionnaire. Subjects were then tested in a first session which lasted approximately three hours. During this period, a comprehensive structured clinical interview was carried out, comprising of an assessment of current and past ADHD symptoms, the history of problems at school, the past psychiatric history (including drug and medication use), as well as past and present comorbidities. Subsequently, EEG data was acquired. EEG data was first recorded while the subject was in eyes-closed and eyes-open resting conditions, lasting four minutes each. Then data was recorded while subjects performed a visual continuous performance task (VCPT). The VCPT took approximately 22 minutes to complete. In addition, subjects randomly performed either an auditory or an emotional continuous performance task.

The control group had a shortened procedure. Subjects were tested in a single session lasting approximately two and a half hours. During this period, a series of questionnaires (Brief Symptom Inventory, Health History questionnaire, Current Symptoms Scales) were filled out and thereafter, EEG data was acquired. Subsequently, a working memory task, which is not relevant here, was administered.

EEG was recorded using a Mitsar 201 19-channel electroencephalographic system. The input signals referenced to the linked ears were filtered between 0.5 and 50 Hz and digitized at a sampling rate of 250 Hz. Impedance was kept below 5 kOhm for all electrodes. Electrodes were placed according to the International 10-20 system using a electrode cap. Quantitative data was calculated using WinEEG software. Linked ears reference montage was changed to average reference montage prior to data processing. Eye-blink artefacts were corrected by zeroing the activation curves of individual ICA component score responding to eye blinks. In addition, epochs of the filtered electroencephalogram with excessive amplitude (>100 μV) and/or excessive fast (>35 μV in 20 to 35 Hz band) and slow (>50 μV in 0 to 1 Hz band) activity were automatically marked and excluded from further analysis. Finally, EEG was manually inspected to verify artefact removal.

Behavioral task

The VCPT is a modification of the visual two-stimulus GO/NOGO paradigm. Three categories of visual stimuli were selected: 20 pictures of animals, 20 pictures of plants, and 20 pictures of humans (presented together with an artificial "novel" sound). The trials consisted of presentations of pairs of stimuli: animal-animal (GO trials), animal-plant (NOGO trials), plant-plant (IGNORE trials), and plant-human (NOVEL trials). The trials were grouped into four blocks. In each block a unique set of five animal stimuli, five plant stimuli and five human stimuli was selected. Each block consisted of a pseudo-random presentation of 100 stimuli pairs with equal probability for each trial category.

The task was to press a button as fast as possible in response to GO trials.

According to the task design, two preparatory sets were distinguished in the trials. In the "Continue set" a picture of an animal is presented as the first stimulus and the subject is supposed to prepare to respond. In the "Discontinue set" a picture of a plant is presented as the first stimulus and the subject does not need to prepare to respond.

During the task, subjects were seated in a comfortable chair, 1.5 m in front of a computer screen. The stimuli were presented on a 17 inch monitor using the Psytask (Mitsar Ltd.) software.

The primary outcome was change in score on the QEEG Rating Scale (AMEN questionnaire). The ERP and questionnaire/behavioural assessments will be made at baseline (before stimulation), after the 10-12 days of stimulation, and at 1 and 3 months after stimulation.

This study involved 30 subjects, all aged between 7 and 13. All have been diagnosed with ADHD by a medical professional.

  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 16, 2014