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

NCT03541707 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-05-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Shalvata Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2020-05-31
Completion
2020-12-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03541707 on ClinicalTrials.gov