PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women

Depression Clinical Trial

Official title:

PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867889
• Other study ID #: PregBrain
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2022
• Source: Uppsala University
• Contact: Robert Bodén, Md, ass prof
• Phone: +46186118795
• Email: robert.boden[@]neuro.uu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Pregnancy Related

Intervention

Device:
• iTBS (intermittent theta-burst stimulation)
The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro X100 stimulator and a Cool-B65 A/P coil or a conventional cool-B65 coil. The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The non-shielded side of the cool-B65 A/P coil is placed towards the patient, or if using the cool-B65 coil the centre of the butterfly is placed towards the patient head
• Sham iTBS
The sham iTBS is delivered with MagPro X100 stimulator and a Cool-B65 A/P coil. The coil is placed over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. For all patients electrodes for transcutaneous electrical nerve stimulation (TENS) are applied and if the patient is randomized to sham treatment the shielded side of the coil will be pointing towards the patient's head and there will be a weak TENS current applied instead synchoronously. If the cool-B65 is used the coil is instead angled 90 degrees delivering the pulses into air instead

Locations

Country	Name	City	State
Sweden	Brain Stimulation Unit, Uppsala university hospital	Uppsala	Region Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in MADRS-rating from baseline to day of the last treatment in the blind phase	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	4 weeks
Secondary	Difference in MADRS-rating from baseline to two weeks after first iTBS treatment	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	4 weeks
Secondary	Duration of treatment effects of iTBS on symptoms in depression	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	1 year