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The study will apply state of the art radiology through advanced magnetic resonance imaging (MRI) techniques to investigate structural and functional brain effects of electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS).
As a multi-disciplinary collaboration, imaging findings will be correlated to psychiatric response parameters, neuropsychological functioning as well as neurochemical and genetic biomarkers that can elucidate the underlying mechanisms. The aim is to document both treatment effects and potential harmful effects of ECT and TMS Sample, three groups: ECT: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with ECT. TMS: n = 50 patients in a major depressive episode (bipolar and major depressive disorder) who have accepted treatment with TMS. HC: = 50 age and gender matched healthy volunteers not receiving ECT nor TMS. Observation time: six months, with the time points as specified below. ECT is typically given three times weekly, but exceptions may occur. Hence, time points are specified as the number of ECT treatments given rather than an exact number of days which will vary. Tp1: 2 hours before the first treatment session (day 1, baseline), Tp2: 2 hours after the first treatment session (day 1), Tp3: before the 7th ECT session and corresponding time point for TMS (\~ day 15), Tp4: 1-2 weeks after last treatment session (\~ day 30 - 50), Tp5: 6 months after treatment (\~ day 180), Healthy controls are only assessed at Tp1,2,4,5
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Haukeland University Hospital
Bergen, Vestland, Norway
Start Date
September 27, 2021
Primary Completion Date
December 31, 2025
Completion Date
December 31, 2025
Last Updated
November 26, 2021
150
ESTIMATED participants
Electroconvulsive therapy
DEVICE
rTMS
DEVICE
Lead Sponsor
Haukeland University Hospital
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07310264