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Trigeminal Nerve Stimulation for Attention Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Collaborator:
NeuroSigma, Inc.
Information provided by (Responsible Party):
James McGough, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01388530
First received: June 24, 2011
Last updated: March 23, 2016
Last verified: March 2016
Results First Received: January 26, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Attention-Deficit/Hyperactivity Disorder
Intervention: Device: EMS 7500 Digital Muscle Stimulator

  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
Recruitment was initiated in July 2011 and ended in October 2012. Participants self-identified or were referred from community providers in response to public advertisements.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following informed permission/assent participants were assessed for eligibility and if meeting inclusion/exclusion criteria initiated 8 weeks of open-label Trigeminal Nerve Stimulation (TNS) treatment.

Reporting Groups
  Description
Trigeminal Nerve Stimulation

Open label treatment with trigeminal nerve stimulation in an 8-week trial.

EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.


Participant Flow:   Overall Study
    Trigeminal Nerve Stimulation  
STARTED     25  
COMPLETED     20  
NOT COMPLETED     5  
Lost to Follow-up                 5  



  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
Trigeminal Nerve Stimulation

Open label treatment with trigeminal nerve stimulation in an 8-week trial.

EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.


Baseline Measures
    Trigeminal Nerve Stimulation  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     25  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean (Standard Deviation)
  10.14  (1.98)  
Gender  
[units: participants]
 
Female     1  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     25  



  Outcome Measures
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1.  Primary:   ADHD-IV Rating Scale (ADHD-RS)   [ Time Frame: Baseline and Week 8. ]

2.  Secondary:   Clinical Global Impression - Improvement (CGI-I)   [ Time Frame: Week 8 ]

3.  Secondary:   Conners Global Index - Parent   [ Time Frame: Baseline and Week 8. ]

4.  Secondary:   Attention Network Task - Incongruent Reaction Time   [ Time Frame: Baseline and Week 8. ]


  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
Early terminations were due to ambivalence about participation of social difficulties with compliance. No one left the study for adverse events or safety reasons. There were no clinically meaningful adverse events related to treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James McGough, M.D.
Organization: David Geffen School of Medicine at UCLA
phone: 310-794-7841
e-mail: jmcgough@mednet.ucla.edu



Responsible Party: James McGough, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01388530     History of Changes
Other Study ID Numbers: UCLA-TNS/ADHD
Study First Received: June 24, 2011
Results First Received: January 26, 2013
Last Updated: March 23, 2016
Health Authority: United States: Institutional Review Board