PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women

Not Applicable

Withdrawn

• Conditions: Depression; Pregnancy Related
• Interventions: Device: iTBS (intermittent theta-burst stimulation); Device: Sham iTBS

• Registration Number: NCT04867889
• Lead Sponsor: Uppsala University

Brief Summary

Background:

Depression during pregnancy is common, afflicting 10-20% of pregnant women. Nevertheless, many women want to avoid antidepressant treatment during pregnancy, due to the possible impact on the unborn child.

rTMS (repetitive transcranial magnetic stimulation) is a method where an electromagnetic coil is placed close to the head. Magnetic pulses will induce an electrical current in specific nerve cells, depending on how the coil is placed. Thousands of patients have been treated with rTMS to date, and the effect on depressive symptoms is well documented, although the exact mechanism of the effect is not yet fully understood. Of late, an alternative treatment regime called intermittent theta burst stimulation (iTBS) has been developed. The treatment time per session for iTBS is much shorter than standard rTMS, which will render the treatment much more clinically acceptable. rTMS in pregnancy has not been extensively studied, but seems to have good effect and few side effects.

Method:

Pregnant women (N=60) with depressive symptoms will be assessed by a psychiatrist, and women fulfilling the criteria for a moderate-severe depressive episode can be included. Participants will be randomized to either active or sham treatment. Treatment will be administered during 20 days, once daily (4 minutes per session). A psychiatrist will assess depressive symptoms before, as well as 2 and 4 weeks after, treatment start. Women randomized to the sham treatment will, after the initial blind phase, be offered active treatment, following the same protocol as above. Women who have responded to the treatment, but are not in remission after the first four weeks will be offered an additional two weeks of iTBS treatment, in accordance with clinical protocol.

Three, 6 and 12 months after the treatment is completed, all participants will be followed up via a web-based questionnaire.

Apart from assessment of mood symptoms, treatment effects is also assessed using structural and functional magnetic resonance imaging (MRI). MRI will be performed once before treatment start, and once before at the very end of the blind phase of the study (four weeks).

A random selection of the participating women will be invited to a sub-study and interviewed once during pregnancy as well as a second time 4-6 months postpartum. Questions will include inter alia their own description of being pregnant and depressed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-30
• Study Start: 2022-12-31
• Primary Completion: 2023-12-31
• Study Completion: 2024-02-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Pregnant women over the age of 18 with a diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.) (44), and with unchanged medication the past month.
2. Provision of signed informed consent form

Exclusion Criteria

1. Epilepsy, conductive ferromagnetic or other magnetic sensitive metals implanted in the head or within 30 cm of the treatment coil (examples cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments), implanted device that is activated or controlled in any way by physiological signals such as pacemakers, implantable cardioverter-defibrillators (ICD's), vagus nerve stimulators, wearable cardioverter-defibrillators, implanted mediation pumps, intracardiac lines, even when removed, addiction (illicit drugs or alcohol), pre-eclampsia/eclampsia, previous preterm birth and/or treatment with any medication that could lower the threshold for seizures.
2. Any condition that seriously increases the risk of non-compliance or loss of follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment iTBS	iTBS (intermittent theta-burst stimulation)	Magnetic pulses of 120% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in 20 sessions on 20 week days, one session per day.
Sham treatment	Sham iTBS	Sham treatment given either with a sham stimulation coil or by flipping an active coil 90 degrees.

Primary Outcome Measures

Name	Time	Method
Difference in MADRS-rating from baseline to day of the last treatment in the blind phase	4 weeks	Montgomery-Asberg Depression Rating Scale (MADRS) is a 10 item rating scale for depressive symptoms ranging from 0-60 points where a higher score indicates worse symptoms

Secondary Outcome Measures

Name	Time	Method
Difference in MADRS-rating from baseline to two weeks after first iTBS treatment	4 weeks	Montgomery-Asberg Depression Rating Scale (MADRS) is a 10 item rating scale for depressive symptoms ranging from 0-60 points where a higher score indicates worse symptoms
Duration of treatment effects of iTBS on symptoms in depression	1 year	Montgomery-Asberg Depression Rating Scale (MADRS) is a 10 item rating scale for depressive symptoms ranging from 0-60 points where a higher score indicates worse symptoms

Trial Locations

Locations (1)

Brain Stimulation Unit, Uppsala university hospital; 🇸🇪 Uppsala, Region Uppsala, Sweden