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

NCT02323633 | Unknown Phase 2 DMC

• 1 other identifier: BGX-3006
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

Pediatric Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• 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

  42 days

• 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.

  42 days

Secondary Outcomes (2)

• 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

  42 days

• The change from baseline to day 42 in the electrophysiological observations of a qEEG.

  42 days

Study Arms (2)

tPCS group

ACTIVE COMPARATOR

Arm in which random noise oscillating frequencies will be produced for the duration of 20 minutes.

Device: Braingear Brainbuds Pulsed Current stimulation device

Sham group

SHAM COMPARATOR

Arm in which no random noise oscillating frequencies will be produced for the duration of 20 minutes

Device: Sham

Interventions

Braingear Brainbuds Pulsed Current stimulation device DEVICE

Transcranial Pulsed Current stimulation (tPCS) at random noise oscillating frequencies for a duration of 20 minutues

tPCS group

Sham DEVICE

No transcranial Pulsed Current Stimulation (tPCS)

Also known as: Braingear Brainbuds Pulsed Current stimulation device

Sham group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Braingear Technologies GmbH: lead
• Spaulding Rehabilitation Hospital: collaborator

Related Publications (19)

• Aosaki T, Graybiel AM, Kimura M. Effect of the nigrostriatal dopamine system on acquired neural responses in the striatum of behaving monkeys. Science. 1994 Jul 15;265(5170):412-5. doi: 10.1126/science.8023166.

  PMID: 8023166 BACKGROUND

• Zaghi S, Acar M, Hultgren B, Boggio PS, Fregni F. Noninvasive brain stimulation with low-intensity electrical currents: putative mechanisms of action for direct and alternating current stimulation. Neuroscientist. 2010 Jun;16(3):285-307. doi: 10.1177/1073858409336227. Epub 2009 Dec 29.

  PMID: 20040569 BACKGROUND

• Wilens T, Pelham W, Stein M, Conners CK, Abikoff H, Atkins M, August G, Greenhill L, McBurnett K, Palumbo D, Swanson J, Wolraich M. ADHD treatment with once-daily OROS methylphenidate: interim 12-month results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):424-33. doi: 10.1097/01.CHI.0000046814.95464.7D.

  PMID: 12649629 BACKGROUND

• Stergiakouli E, Thapar A. Fitting the pieces together: current research on the genetic basis of attention-deficit/hyperactivity disorder (ADHD). Neuropsychiatr Dis Treat. 2010 Sep 7;6:551-60. doi: 10.2147/NDT.S11322.

  PMID: 20856918 BACKGROUND

• Sprich S, Biederman J, Crawford MH, Mundy E, Faraone SV. Adoptive and biological families of children and adolescents with ADHD. J Am Acad Child Adolesc Psychiatry. 2000 Nov;39(11):1432-7. doi: 10.1097/00004583-200011000-00018.

  PMID: 11068899 BACKGROUND

• Shealy YF. Synthesis and evaluation of some new retinoids for cancer chemoprevention. Prev Med. 1989 Sep;18(5):624-45. doi: 10.1016/0091-7435(89)90034-0.

  PMID: 2694159 BACKGROUND

• Voeller KK. Attention-deficit hyperactivity disorder (ADHD). J Child Neurol. 2004 Oct;19(10):798-814. doi: 10.1177/08830738040190100901.

  PMID: 15559895 BACKGROUND

• Goodman R, Stevenson J. A twin study of hyperactivity--II. The aetiological role of genes, family relationships and perinatal adversity. J Child Psychol Psychiatry. 1989 Sep;30(5):691-709. doi: 10.1111/j.1469-7610.1989.tb00782.x.

  PMID: 2793957 BACKGROUND

• Polania R, Nitsche MA, Korman C, Batsikadze G, Paulus W. The importance of timing in segregated theta phase-coupling for cognitive performance. Curr Biol. 2012 Jul 24;22(14):1314-8. doi: 10.1016/j.cub.2012.05.021. Epub 2012 Jun 7.

  PMID: 22683259 BACKGROUND

• Loe IM, Feldman HM. Academic and educational outcomes of children with ADHD. J Pediatr Psychol. 2007 Jul;32(6):643-54. doi: 10.1093/jpepsy/jsl054. Epub 2007 Jun 14.

  PMID: 17569716 BACKGROUND

• Biederman J, Spencer T. Attention-deficit/hyperactivity disorder (ADHD) as a noradrenergic disorder. Biol Psychiatry. 1999 Nov 1;46(9):1234-42. doi: 10.1016/s0006-3223(99)00192-4.

  PMID: 10560028 BACKGROUND

• Brook U, Boaz M. Adolescents with attention deficit and hyperactivity disorder/learning disability and their proneness to accidents. Indian J Pediatr. 2006 Apr;73(4):299-303. doi: 10.1007/BF02825823.

  PMID: 16816490 BACKGROUND

• Datta A, Dmochowski JP, Guleyupoglu B, Bikson M, Fregni F. Cranial electrotherapy stimulation and transcranial pulsed current stimulation: a computer based high-resolution modeling study. Neuroimage. 2013 Jan 15;65:280-7. doi: 10.1016/j.neuroimage.2012.09.062. Epub 2012 Oct 5.

  PMID: 23041337 BACKGROUND

• Edelmuth RC, Nitsche MA, Battistella L, Fregni F. Why do some promising brain-stimulation devices fail the next steps of clinical development? Expert Rev Med Devices. 2010 Jan;7(1):67-97. doi: 10.1586/erd.09.64.

  PMID: 20021241 BACKGROUND

• Arnsten AF, Steere JC, Hunt RD. The contribution of alpha 2-noradrenergic mechanisms of prefrontal cortical cognitive function. Potential significance for attention-deficit hyperactivity disorder. Arch Gen Psychiatry. 1996 May;53(5):448-55. doi: 10.1001/archpsyc.1996.01830050084013.

  PMID: 8624188 BACKGROUND

• Arnsten AF, Li BM. Neurobiology of executive functions: catecholamine influences on prefrontal cortical functions. Biol Psychiatry. 2005 Jun 1;57(11):1377-84. doi: 10.1016/j.biopsych.2004.08.019.

  PMID: 15950011 BACKGROUND

• Bader A, Adesman A. Complementary and alternative therapies for children and adolescents with ADHD. Curr Opin Pediatr. 2012 Dec;24(6):760-9. doi: 10.1097/MOP.0b013e32835a1a5f.

  PMID: 23111680 BACKGROUND

• Ahuja A, Martin J, Langley K, Thapar A. Intellectual disability in children with attention deficit hyperactivity disorder. J Pediatr. 2013 Sep;163(3):890-5.e1. doi: 10.1016/j.jpeds.2013.02.043. Epub 2013 Apr 19.

  PMID: 23608559 BACKGROUND

• Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23. doi: 10.1176/ajp.2006.163.4.716.

  PMID: 16585449 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Johan A Erasmus, MBChB

  Netcare Moot Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maresa Kotze, Hon Genetics

CONTACT

72-602-6720; maresa.kotze@cytespace.com

Abraham A van Wyk, MBA

CONTACT

82-908-0090; abraham.vanwyk@cytespace.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 23, 2014

Record last verified: 2014-12