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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
Results First Received: December 15, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: ADHD
ADD
Intervention: Device: Active tDCS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled at 3 clinics in Spain

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Active tDCS     Controls  
STARTED     30     30  
COMPLETED     28 [1]   30  
NOT COMPLETED     2     0  
Physician Decision                 2                 0  
[1] technical problems or excessive artifacts, two data sets were excluded from further analysis.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active tDCS Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
Controls Healthy people that not receive tDCS
Total Total of all reporting groups

Baseline Measures
    Active tDCS     Controls     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     19     14     33  
Between 18 and 65 years     11     16     27  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  20.06  ± 13.03     33.12  ± 22.80     25.14  ± 18.09  
Gender  
[units: participants]
     
Female     9     12     21  
Male     21     18     39  
Region of Enrollment  
[units: participants]
     
Spain     30     30     60  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Assessment (Amen Questionnaire)   [ Time Frame: From September to December 2012 ]

2.  Secondary:   Event-related Potentials Amplitude (ERPs)   [ Time Frame: From September to December 2012 ]

3.  Secondary:   Event-related Potentials Latency (ERPs)   [ Time Frame: From September to December 2012 ]

4.  Secondary:   Reaction Time (Behavior Task)   [ Time Frame: From September to December 2012 ]

5.  Secondary:   Number of Omission and Commission Errors of Behavior Task   [ Time Frame: From September to December 2012 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Moises Aguilar-Domingo, Chairman of Spanish Neurometrics Foundation
Organization: Spanish Neurometrics Foundation
phone: +34 634548720
e-mail: moises.aguilar@gmail.com


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