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

NCT03541707 | Unknown

• 1 other identifier: 0020-17 SHA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

TMS; EEG; Depression; adolescents

Outcome Measures

Primary Outcomes (2)

• For efficacy, improvement in the CGI is the primary outcome measure.

  Efficacy will be examined by the improvement in Clinical global Impression(CGI).

  24 months

• For safety, severe side effects are the primary outcome measure.

  Safety will be examined by Incidence of Treatment-Emergent Adverse Events

  24 months

Secondary Outcomes (1)

• cognitive changes in response to the treatment

  24 months

Study Arms (2)

Active Therapy

ACTIVE COMPARATOR

Device: Deep TMS Brainsway's H coil

"As if" Stimulation

SHAM COMPARATOR

Device: Deep TMS Brainsway's H coil

Interventions

Deep TMS Brainsway's H coil DEVICE

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.

Also known as: EEG (MindWave of NeuroSky LTD)

"As if" Stimulation; Active Therapy

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata Mental health Center

Hod HaSharon, Israel

Location

MeSH Terms

Conditions

Depression

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Child and Adolescent Outpatient clinic and Research Unit

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 30, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

IL (1)