Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders

NCT ID: NCT02917499

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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The goal of this study is to examine the efficacy and safety of transcranial magnetic stimulation (TMS) and deep TMS (dTMS) for treatment of different psychiatric and neurological disorders. Subjects will be randomized into two groups: experimental (treated with pharmacotherapy and TMS) and control group (treated only with pharmacotherapy). They and their clinicians will complete a battery of instruments that measure relevant symptoms, global functioning and quality of life. The first measurement will be done after the inclusion and before treatment. The second measurement will be made immediately after the end of treatment (after 4 weeks). The other measurements (follow-up) will be made after 3 and 6 months.

Detailed Description

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Conditions

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Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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TMS

The experimental group will be treated with transcranial magnetic stimulation for 4 weeks.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

Transcranial magnetic stimulation

noTMS

The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TMS

Transcranial magnetic stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan

Exclusion Criteria

* suicidality, psychosis, alcohol addiction, unable to complete the questionnaires
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sveti Ivan Psychiatric Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PB Sveti Ivan

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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Filipcic I, Simunovic Filipcic I, Milovac Z, Sucic S, Gajsak T, Ivezic E, Basic S, Bajic Z, Heilig M. Efficacy of repetitive transcranial magnetic stimulation using a figure-8-coil or an H1-Coil in treatment of major depressive disorder; A randomized clinical trial. J Psychiatr Res. 2019 Jul;114:113-119. doi: 10.1016/j.jpsychires.2019.04.020. Epub 2019 Apr 26.

Reference Type DERIVED
PMID: 31059991 (View on PubMed)

Other Identifiers

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TMS

Identifier Type: -

Identifier Source: org_study_id

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