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Phase IIa Exploratory Clinical Trial, to Examine the Safety and Efficacy of tPCS on Paediatric ADHD Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323633
Recruitment Status : Unknown
Verified December 2014 by Braingear Technologies GmbH.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2014
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Braingear Technologies GmbH

Brief Summary:

Children with ADHD display a certain brainwave profile which might be different to that of a child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation) has shown that this brainwave profile could possibly be altered to more closely resemble a brainwave profile of a child who does not have ADHD. Researchers believe that by changing this brainwave profile it might lessen symptoms of ADHD.

tPCS is a name used to describe the type of current this device produces. It involves randomly (in no specific pattern) produced pulses of current at different times that the brain picks up. These pulses of low current stimulate the brain in a certain way and affect the brainwave activity.

Treatment is given by applying a low frequency current using small electrodes clipped to the earlobes. The current comes from an external battery source. The pulses of current generated by this device stimulate certain parts of the brain which result in a possible increased control of attention and behaviour. This treatment has already been proven to be safe and will not hurt your child.

Due to these specific parts of the brain being stimulated, and the positive results of previous research, it seems possible to control certain functions in children suffering from inattention and hyperactivity.

The idea of using tPCS stimulation as a possible way for helping children with confirmed ADHD opens a new window to future research. The final goal of this device and research is to offer a safe, non-invasive (conservative treatment that does not require piercing into the body or the removal of tissue) treatment that can be used on a long-term basis and shows a clear improvement of ADHD symptoms for children and even adults with ADHD.


Condition or disease Intervention/treatment Phase
Attention Deficit Disorder With Hyperactivity Device: Braingear Brainbuds Pulsed Current stimulation device Device: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-blind, Randomised, Sham Controlled, Phase IIa Exploratory Clinical Trial, to Examine the Safety and Efficacy of BGX-3006 (tPCS) on Paediatric ADHD Participants.
Study Start Date : January 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tPCS group
Arm in which random noise oscillating frequencies will be produced for the duration of 20 minutes.
Device: Braingear Brainbuds Pulsed Current stimulation device
Transcranial Pulsed Current stimulation (tPCS) at random noise oscillating frequencies for a duration of 20 minutues

Sham Comparator: Sham group
Arm in which no random noise oscillating frequencies will be produced for the duration of 20 minutes
Device: Sham
No transcranial Pulsed Current Stimulation (tPCS)
Other Name: Braingear Brainbuds Pulsed Current stimulation device




Primary Outcome Measures :
  1. The primary efficacy objective will be measured by the change in scores from baseline to Day 42 in both the SNAP-IV-C and Connors'3 Parent Rating Scales [ Time Frame: 42 days ]
  2. Safety and tolerability will be measured by the incidence and severity of adverse events and changes in physical examination findings, vital signs and qEEG findings. [ Time Frame: 42 days ]

Secondary Outcome Measures :
  1. The secondary efficacy objective will be measured by the change in scores from baseline to day 42 in the psychometric analysis conducted by the psychometrist [ Time Frame: 42 days ]
  2. The change from baseline to day 42 in the electrophysiological observations of a qEEG. [ Time Frame: 42 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of the written informed consent process for trial participation, by parent(s) or legal guardian(s), prior to all trial-related procedures
  • Completion of written assent for trial participation, by participant, prior to all trial-related procedures
  • Male or female participants aged 6 to 12 years
  • Newly diagnosed (Diagnosis made by DSM-V criteria), treatment naïve participants
  • Participants and parent(s) or legal guardian(s) must have the ability to communicate well with the investigator and to understand and comply with the requirements of the trial
  • Participants and parent(s) or legal guardian(s) must agree to stay in contact with the trial site for the duration of the trial and provide updated contact information as necessary.

Exclusion Criteria:

  • Existence of a major neurologic or psychiatric condition (epilepsy, severe depression etc.)
  • History of head injury resulting in more than a momentary loss of consciousness
  • Previous neurosurgery
  • Presence of unstable medical conditions, such as: Diabetes Mellitus, Cardiac Pathology, Cancer, Kidney Insufficiency, Acute Thrombosis
  • Presence of any implanted metal or electronic medical devices present in the head, excluding any dental implants
  • Subjects on any prohibited concomitant medication
  • Any other medical condition which, in the opinion of the Investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial
  • In the opinion of the investigator, the participant and his/her parent(s) or legal guardian(s) is not reliable for participation in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323633


Contacts
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Contact: Maresa Kotze, Hon Genetics 72-602-6720 ext +27 maresa.kotze@cytespace.com
Contact: Abraham A van Wyk, MBA 82-908-0090 ext +27 abraham.vanwyk@cytespace.com

Sponsors and Collaborators
Braingear Technologies GmbH
Spaulding Rehabilitation Hospital
Investigators
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Principal Investigator: Johan A Erasmus, MBChB Netcare Moot Hospital
Publications:

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Responsible Party: Braingear Technologies GmbH
ClinicalTrials.gov Identifier: NCT02323633    
Other Study ID Numbers: BGX-3006
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014
Keywords provided by Braingear Technologies GmbH:
Pediatric Attention Deficit Hyperactivity Disorder
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases