The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments (FundECT)

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).

Study Overview

• Status: Recruiting
• Conditions: Healthy; Major Depressive Disorder; Major Depressive Disorder 1
• Intervention / Treatment: Device: Electroconvulsive therapy; Device: rTMS

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Leif Oltedal, PhD; Phone Number: +47 5597388; Email: leif.oltedal@uib.no
• Study Contact Backup: Name: Leila Fried, Master; Phone Number: +47 55974513; Email: leila.frid@helse-bergen.no

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Recruiting
      • Haukeland University Hospital
      • Contact: Leila Frid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

ECT:

• Patients (>18) referred to the center of ECT and accepted for treatment
• because of moderate and severe depression
• fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
• In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
• There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).

TMS:

• Patients (>18) referred to the center of TMS and accepted for treatment
• because of moderate and severe depression
• fulfilling the criteria for the following ICD-10 diagnosis: F 31.3 and F31.4; F32.1 and F32.2 and F32.3; F33.1 and F33.2 and F33.3.
• In addition, the symptom intensity must be verified by a MADRS score ≥ 25.
• There is no upper age for participation, however, the responsible clinician will consider if patients are eligible for inclusion (functioning, enabled to give informed consent).

Healthy controls:

• Age and gender matched (to the patient groups).
• No history of psychiatric illness and no current depression.
• No contraindication for MRI scanning.

Exclusion Criteria:

• ECT / TMS treatment within the last 12 months.
• Patients unable to give informed consent (according to the responsible clinician or ECT / TMS responsible).
• Patients who cannot participate in the MR scanning

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients, depression, ECT; Patients in major depressive episode undergoing ECT	Device: Electroconvulsive therapy; Treatment with Electroconvulsive therapy
Patients, depression, TMS; Patients in major depressive episode undergoing TMS	Device: rTMS; repetitive Transcranial Magnetic Stimulation
Healthy; Healthy controls who do not receive ECT nor TMS but otherwise the same assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Collaborators: University of Bergen

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Mood Disorders; Depression; Depressive Disorder; Disease; Depressive Disorder, Major
• Other Study ID Numbers: 254425

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No