Trial Outcomes & Findings for ADHD Electrophysiological Subtypes and Implications in Transcranial Direct-current Stimulation (NCT NCT01649232)

NCT ID: NCT01649232

Last Updated: 2024-05-09

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 60 participants
• Primary outcome timeframe: From September to December 2012
• Results posted on: 2024-05-09

Participant Flow

Subjects were screened and enrolled at 3 clinics in Spain

Participant milestones

Measure	Active tDCS Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days. 55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe).	Controls Healthy people that not receive tDCS
Overall Study STARTED	30	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Active tDCS Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days. 55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe).	Controls Healthy people that not receive tDCS
Overall Study Physician Decision	2	0

Baseline Characteristics

ADHD Electrophysiological Subtypes and Implications in Transcranial Direct-current Stimulation

Baseline characteristics by cohort

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls n=30 Participants Healthy people that not receive tDCS	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	16 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	20.06 years STANDARD_DEVIATION 13.03 • n=5 Participants	33.12 years STANDARD_DEVIATION 22.80 • n=7 Participants	25.14 years STANDARD_DEVIATION 18.09 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Region of Enrollment Spain	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: From September to December 2012

Population: The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.

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.

Outcome measures

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Control Group n=30 Participants Healthy people that not receive tDCS	Active tDCS at 3 Months Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls at 3 Months Healthy people that not receive tDCS
Clinical Assessment (Amen Questionnaire) Amen Average Scale Pre_tDCS	9.85 units on a scale Standard Deviation 1.55	3.55 units on a scale Standard Deviation 1.20	—	—
Clinical Assessment (Amen Questionnaire) Amen Average Scale Post_tDCS at 3 months	5.15 units on a scale Standard Deviation 1.83	3.54 units on a scale Standard Deviation 1.21	—	—

SECONDARY outcome

Timeframe: From September to December 2012

Population: The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.

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.

Outcome measures

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Control Group n=30 Participants Healthy people that not receive tDCS	Active tDCS at 3 Months n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls at 3 Months n=30 Participants Healthy people that not receive tDCS
Event-related Potentials Amplitude (ERPs) Pz GO amplitude	6.07 microVolts Standard Deviation 2.20	5.40 microVolts Standard Deviation 2.28	4.96 microVolts Standard Deviation 2.28	4.77 microVolts Standard Deviation 2.12
Event-related Potentials Amplitude (ERPs) Cz NOGO amplitude	9.22 microVolts Standard Deviation 3.59	7.01 microVolts Standard Deviation 4.52	7.23 microVolts Standard Deviation 2.49	7.21 microVolts Standard Deviation 2.19

SECONDARY outcome

Timeframe: From September to December 2012

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.

Outcome measures

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Control Group n=30 Participants Healthy people that not receive tDCS	Active tDCS at 3 Months n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls at 3 Months n=30 Participants Healthy people that not receive tDCS
Event-related Potentials Latency (ERPs) Pz GO latency	323.78 milliseconds Standard Deviation 10.60	324.44 milliseconds Standard Deviation 16.49	321.56 milliseconds Standard Deviation 13.33	326.21 milliseconds Standard Deviation 15.11
Event-related Potentials Latency (ERPs) Cz NOGO latency	348.67 milliseconds Standard Deviation 17.89	354.00 milliseconds Standard Deviation 15.17	348.22 milliseconds Standard Deviation 16.38	352.17 milliseconds Standard Deviation 14.91

SECONDARY outcome

Timeframe: From September to December 2012

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.

Outcome measures

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Control Group n=30 Participants Healthy people that not receive tDCS	Active tDCS at 3 Months n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls at 3 Months n=30 Participants Healthy people that not receive tDCS
Reaction Time (Behavior Task) Reaction Time Before tDCS	466.95 milliseconds Standard Deviation 109.70	354.68 milliseconds Standard Deviation 39.02	444.65 milliseconds Standard Deviation 110.56	356.58 milliseconds Standard Deviation 40.01
Reaction Time (Behavior Task) Reaction time after tDCS	467.04 milliseconds Standard Deviation 124.44	352.29 milliseconds Standard Deviation 35.49	412.49 milliseconds Standard Deviation 98.41	351.27 milliseconds Standard Deviation 35.02

SECONDARY outcome

Timeframe: From September to December 2012

Population: The number of participants needed for study completion is between 20 and 40 for pilot study if it is homogeneous in patients with clinical signs and symptoms, to test efficacy and safety of noninvasive Brain Stimulation.

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.

Outcome measures

Measure	Active tDCS n=30 Participants Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Control Group n=30 Participants Healthy people that not receive tDCS	Active tDCS at 3 Months Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls at 3 Months Healthy people that not receive tDCS
Number of Omission and Commission Errors of Behavior Task Omission Errors pre tDCS GO cues	11.22 Number of omission and commision errors Standard Deviation 10.64	1.07 Number of omission and commision errors Standard Deviation 1.27	—	—
Number of Omission and Commission Errors of Behavior Task Omission Errors post tDCS at 3 months GO cues	12.22 Number of omission and commision errors Standard Deviation 16.54	1.04 Number of omission and commision errors Standard Deviation 1.29	—	—
Number of Omission and Commission Errors of Behavior Task Comission Errors pre tDCS NOGO cues	0.83 Number of omission and commision errors Standard Deviation 3.34	0.04 Number of omission and commision errors Standard Deviation 0.19	—	—
Number of Omission and Commission Errors of Behavior Task Comission Errosr post tDCS at 3 months NOGO cues	0.30 Number of omission and commision errors Standard Deviation 1.02	0.04 Number of omission and commision errors Standard Deviation 0.19	—	—

Adverse Events

Active tDCS

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS n=30 participants at risk Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days	Controls n=30 participants at risk Healthy people that not receive tDCS
Nervous system disorders headache	10.0% 3/30 • Number of events 3 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.	0.00% 0/30 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.
Nervous system disorders headedness / dizziness	10.0% 3/30 • Number of events 3 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.	0.00% 0/30 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.
General disorders fatigue or nausea	6.7% 2/30 • Number of events 2 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.	0.00% 0/30 • From September to December 2012 The adverse events are reported by nurse like at the end of every session.

Additional Information

Dr. Moises Aguilar-Domingo, Chairman of Spanish Neurometrics Foundation

Spanish Neurometrics Foundation

Phone: +34 634548720

Email: moises.aguilar@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place