Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
Primary Purpose
Mood Disorders
Status
Completed
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
TMS
Sponsored by
About this trial
This is an interventional treatment trial for Mood Disorders
Eligibility Criteria
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
Sites / Locations
- PB Sveti Ivan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
TMS
noTMS
Arm Description
The experimental group will be treated with transcranial magnetic stimulation for 4 weeks.
The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02917499
First Posted
September 14, 2016
Last Updated
June 23, 2019
Sponsor
Sveti Ivan Psychiatric Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02917499
Brief Title
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sveti Ivan Psychiatric Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
228 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS
Arm Type
Experimental
Arm Description
The experimental group will be treated with transcranial magnetic stimulation for 4 weeks.
Arm Title
noTMS
Arm Type
No Intervention
Arm Description
The control (no intervention) group will be treated as usual (with pharmacotherapy). These patients will receive TMS treatment after data collection is ended.
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
Transcranial magnetic stimulation
Primary Outcome Measure Information:
Title
the proportion of patients who experienced complete remission of the disease
Description
Measurement points: immediately after the end of treatment, and follow-up after 3 and 6 months.
Time Frame
up to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
PB Sveti Ivan
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
31059991
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of TMS and Deep TMS Treatment for Psychiatric and Neurological Disorders
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