Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
1 other identifier
interventional
228
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 25, 2019
June 1, 2019
1.1 years
September 14, 2016
June 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
the proportion of patients who experienced complete remission of the disease
Measurement points: immediately after the end of treatment, and follow-up after 3 and 6 months.
up to six months
Study Arms (2)
TMS
EXPERIMENTALThe experimental group will be treated with transcranial magnetic stimulation for 4 weeks.
noTMS
NO INTERVENTIONThe control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.
Interventions
Eligibility Criteria
You may qualify if:
- diagnosed psychiatric or neurological disorder, duration of disorder for at least 5 years, inpatients or outpatients treated in Psychiatric hospital Sveti Ivan
You may not qualify if:
- suicidality, psychosis, alcohol addiction, unable to complete the questionnaires
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PB Sveti Ivan
Zagreb, 10000, Croatia
Related Publications (1)
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.
PMID: 31059991DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2016
First Posted
September 28, 2016
Study Start
December 1, 2016
Primary Completion
January 1, 2018
Study Completion
December 1, 2018
Last Updated
June 25, 2019
Record last verified: 2019-06