DepressionNCT04867889
PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
A study testing iTBS (intermittent theta-burst stimulation) in people with Depression and Pregnancy Related, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Depression, Pregnancy Related
- What is being tested?
- iTBS (intermittent theta-burst stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- 31 Dec 2022to 9 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Provision of signed informed consent form
Who cannot join
- 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.
- Any condition that seriously increases the risk of non-compliance or loss of follow-up
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Brain Stimulation Unit, Uppsala university hospital
Uppsala, Region Uppsala, 75334
About this study
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.
Read more
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.
- Conditions
- Depression, Pregnancy Related
- Being tested
- iTBS (intermittent theta-burst stimulation), Sham iTBS
- Keywords
- depression, pregnancy, transcranial magnetic stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iTBS (intermittent theta-burst stimulation)Device
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 iTBSDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment iTBS | Active comparator | 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. Receives: Device: iTBS (intermittent theta-burst stimulation) |
| Sham treatment | Sham comparator | Sham treatment given either with a sham stimulation coil or by flipping an active coil 90 degrees. Receives: Device: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (2)
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
Measured: 4 weeks
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start31 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion9 Feb 2024
Why it stopped: Difficult to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a four week parallel randomized controlled trial, with two arms; the first following a protocol for magnetic stimulation of the brain with intermittent theta-burst stimulation (iTBS), with one session daily for four weeks, and the other the same protocol with a sham coil (both treatment arms will have 20 sessions in total). Apart from assessment of mood symptoms, treatment effects is also assessed using structural and functional magnetic resonance imaging. 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Boden, Uppsala University
- Investigators
- Robert Bodén, MD, ass prof, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867889
- Sponsor's protocol ID
- PregBrain
- Status last verified
- Jul 2024
- First submitted
- 27 Apr 2021
- Last updated
- 19 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREGBRAIN - Magnetic Stimulation of the Brain in Depressed Pregnant Women
- ClinicalTrials.gov ID
- NCT04867889
- Acronym / sponsor ID
- PregBrain
- Conditions
- Depression, Pregnancy Related
- Keywords
- depression, pregnancy, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 31 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a four week parallel randomized controlled trial, with two arms; the first following a protocol for magnetic stimulation of the brain with intermittent theta-burst stimulation (iTBS), with one session daily for four weeks, and the other the same protocol with a sham coil (both treatment arms will have 20 sessions in total). Apart from assessment of mood symptoms, treatment effects is also assessed using structural and functional magnetic resonance imaging. 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.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment iTBS | Active comparator | Device: 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 comparator | Device: Sham iTBSSham treatment given either with a sham stimulation coil or by flipping an active coil 90 degrees. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
- Provision of signed informed consent form
Key exclusion criteria (2 listed)
- 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.
- Any condition that seriously increases the risk of non-compliance or loss of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Active Treatment iTBS |
| Sham iTBSThe 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 | Device | Sham treatment |
Primary outcome
Difference in MADRS-rating from baseline to day of the last treatment in the blind phase
Time frame: 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
2 secondary outcomes
Difference in MADRS-rating from baseline to two weeks after first iTBS treatment
Time frame: 4 weeks
Duration of treatment effects of iTBS on symptoms in depression
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bodén, MD, ass prof principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iTBS (intermittent theta-burst stimulation) in people with Depression and Pregnancy Related, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in MADRS-rating from baseline to day of the last treatment in the blind phase (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.