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Evaluation of the H1-Coil TMS- Double Blind Placebo Controlled Study in Adolescent Patients Suffering From Major Depression

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ClinicalTrials.gov Identifier: NCT03541707
Recruitment Status : Not yet recruiting
First Posted : May 30, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Yuval Bloch, Shalvata Mental Health Center

Brief Summary:

This study is a randomized double blind placebo controlled EEG monitored study of deep rTMS treatment to treat adolescent depression.

The present study is the first well controlled study to examine the possible clinical utility of deep TMS to treat a severe and life threatening disorder- depression, among adolescents.

Patients will be allocated, based on chance, to receive active therapy or a "as if" stimulation, with no knowledge of patient or therapist who receives the active therapy. In addition, a simple and feasible monitoring of brain waves (EEG) will be conducted. This addition will enable us to evaluate the possibility to use biological markers to predict the course of therapy.

Our hypothesis is that 1. patients receiving the active therapy will improve significantly more than those who received the "as if" treatment. 2. There will be no significant side effects. 3. The brain waves (as measured by the EEG) will predict treatment response.


Condition or disease Intervention/treatment Phase
Depression Device: Deep TMS Brainsway's H coil Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Fifty-two adolescent patients suffering from major depression that are still severely ill after at least one psychological treatment and at least 2 adequate treatments knowledge of patient or doctor who receives the active therapy. Patients will be evaluated for efficacy, side effects, and cognitive performance. Brain waves (using EEG) will be monitored to see if they can predict who will respond to deep TMS.with medications, will be recruited. After the informed consent of guardians and patients, a systematic clinical evaluation with the aid of appropriate questionnaires will be performed. Patients will be allocated in a randomized double blind placebo controlled manner to dTMS or Sham treatments for about half an hour per day over 20 consecutive working days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Patients will be allocated, based on chance, to receive active therapy or a "as if" stimulation, with no knowledge of patient or therapist who receives the active therapy
Primary Purpose: Treatment
Official Title: Evaluation of the H1-Coil TMS- Double Blind Placebo Controlled Study in Adolescent Patients Suffering From Major Depression.
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Therapy Device: Deep TMS Brainsway's H coil

During the treatment trial period all subjects will receive the following dose of TMS: 18 Hz, at 100% RMT, 2 sec pulse train, 20 second inter-train interval, 80 trains, for a total of 57,600 pulses over the complete treatment course. In the placebo group a state of the art sham procedure will be used- the coil is programed to produce the noise and local sensation but with no activation.

EEG Recording is done with and without an acoustic oddball trigger, in order to have both resting state and event related recordings. The evaluation takes approximately 5 minutes.

Other Name: EEG (MindWave of NeuroSky LTD)

Sham Comparator: "As if" Stimulation Device: Deep TMS Brainsway's H coil

During the treatment trial period all subjects will receive the following dose of TMS: 18 Hz, at 100% RMT, 2 sec pulse train, 20 second inter-train interval, 80 trains, for a total of 57,600 pulses over the complete treatment course. In the placebo group a state of the art sham procedure will be used- the coil is programed to produce the noise and local sensation but with no activation.

EEG Recording is done with and without an acoustic oddball trigger, in order to have both resting state and event related recordings. The evaluation takes approximately 5 minutes.

Other Name: EEG (MindWave of NeuroSky LTD)




Primary Outcome Measures :
  1. For efficacy, improvement in the CGI is the primary outcome measure. [ Time Frame: 24 months ]
    Efficacy will be examined by the improvement in Clinical global Impression(CGI).

  2. For safety, severe side effects are the primary outcome measure. [ Time Frame: 24 months ]
    Safety will be examined by Incidence of Treatment-Emergent Adverse Events


Secondary Outcome Measures :
  1. cognitive changes in response to the treatment [ Time Frame: 24 months ]
    As measured by cognitive evaluation using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP)



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 14-18 years.
  • Diagnosed as suffering from major depression by two senior child and adolescent psychiatrist according to DSM 5 criteria, and validated with the development and well-being assessment (DAWBA) interview[34].
  • Severe depression as assessed by the child depression rating scale (CDRS)[35] of 40 or more, and the clinical global impression scale (CGI)[36] of 4 or more.
  • They have had at least 2 antidepressant drug trials of at least 5 weeks (or 3 drug trials if trials were discontinued earlier due to intolerance), beyond psychotherapy.
  • They scored negative on all TMS safety questionnaire.
  • There was no change in pharmacotherapy in the past 3 weeks.
  • Both patients and guardians have given an informed consent.
  • Patients are under continued clinical monitoring.

Exclusion Criteria:

  • Patients suffering from schizophrenia.
  • Present or history of any general medical or neurological significant disorder including: epilepsies, hypertension, head injuries or neurosurgery, migraine, and hearing loss.
  • Substance abuse in the past 2 weeks.

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): NCT03541707


Locations
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Israel
Shalvata Mental health Center
Hod Hasharon, Israel
Sponsors and Collaborators
Shalvata Mental Health Center

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Responsible Party: Yuval Bloch, Head of Child and Adolescent Outpatient clinic and Research Unit, Shalvata Mental Health Center
ClinicalTrials.gov Identifier: NCT03541707     History of Changes
Other Study ID Numbers: 0020-17 SHA
First Posted: May 30, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yuval Bloch, Shalvata Mental Health Center:
TMS
EEG
Depression
adolescents
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders