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| Name | Class |
|---|---|
| University of Bergen | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients, depression, ECT | Patients in major depressive episode undergoing ECT |
| |
| Patients, depression, TMS | Patients in major depressive episode undergoing TMS |
| |
| Healthy | Healthy controls who do not receive ECT nor TMS but otherwise the same assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroconvulsive therapy | Device | Treatment with Electroconvulsive therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cerebral Blood Flow from baseline | Estimated by Arterial Spin Labeling MRI | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
| Change in MADRS from baseline | Depression rating by MADRS score | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change fraction of in Isotropic hindered water | Measured by Restriction spectrum imaging. Increase in the fraction of isotropic hindered water as a sign of oedema / disruptive effects of ECT seen on Imaging at 2 hours after first ECT. | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
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Inclusion Criteria:
ECT:
TMS:
Healthy controls:
Exclusion Criteria:
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Patients accepted for ECT or TMS at Haukeland University Hospital will be included.
Control groups: Healthy controls undergoing the same investigations as the ECT and TMS patient groups, but not receiving any treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leif Oltedal, PhD | Contact | +47 5597388 | leif.oltedal@uib.no | |
| Leila Fried, Master | Contact | +47 55974513 | leila.frid@helse-bergen.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | Vestland | 5021 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37904091 | Derived | Frid LM, Kessler U, Ousdal OT, Hammar A, Haavik J, Riemer F, Hirnstein M, Ersland L, Erchinger VJ, Ronold EH, Nygaard G, Jakobsen P, Craven AR, Osnes B, Alisauskiene R, Bartsch H, Le Hellard S, Stavrum AK, Oedegaard KJ, Oltedal L. Neurobiological mechanisms of ECT and TMS treatment in depression: study protocol of a multimodal magnetic resonance investigation. BMC Psychiatry. 2023 Oct 30;23(1):791. doi: 10.1186/s12888-023-05239-0. |
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| ID | Term |
|---|---|
| C563919 | Major Depressive Disorder 1 |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Blood samples
| rTMS |
| Device |
repetitive Transcranial Magnetic Stimulation |
|
| Change in concentration of NAA, Choline, myo Inositol | MR Spectroscopy og the amygdala, measures of neuronal integrity. | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
| Changes in structural MRI T1 and T2 and RSI | Measures of brain structure | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
| Changes in functional MRI | Resting state MRI, measurement of functional connectivity | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |
| Change in performance on test of spatial navigation | Neurocognitive assessments of spatial navigation | Baseline, day1 (after 1 ECT), ~ day 15 (after 6 ECTs), ~ day 30 - 50 (1-2 weeks after last ECT), ~ day 180 (6 months after treatment) |