Accelerated TMS for Perinatal Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorBrigham and Women's Hospital
About this trial
We are studying a treatment for depression called accelerated Transcranial Magnetic Stimulation (TMS) among pregnant and postpartum individuals. TMS is a focal, non-invasive form of brain stimulation that is cleared by the Food and Drug Administration for depression. Typically, traditional TMS involves daily treatments for 6-8 weeks. In this study, we will offer an accelerated form of TMS that involves multiple daily treatments for 5 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-55
All individuals must be 14-34 weeks gestational age or within one year of delivery at the time of treatment. The odds of delivery nears 10% after 36 weeks, which would limit participants from being able to complete the study and interfere with the primary study aim to understand safety and tolerability. Additionally, after 36 weeks, the standard of care is weekly obstetric check-in visits, which would be challenging for patients to complete given the time demands of the study protocol.
Patients will not be scanned after 32 weeks gestational age due to the time needed to construct the individualized treatment target. Individuals seeking treatment beyond 32 weeks will be offered scalp-based target localization so as not to limit patient access to care.
English proficiency sufficient for informed consent, questionnaires/tasks, and treatment
Disqualifiers
Concurrent use of rapid acting antidepressant agent (ketamine/esketamine/ECT)
Receiving or planning to receive other TMS treatments during course of participation
Obstetric concerns: Preeclampsia and/or current frequent, painful contractions (more than one every 10 minutes)
History of: Neurosurgical intervention for depression, autism spectrum disorder, intellectual disability, severe cognitive impairment, significant neurological illness (e.g., dementia, Parkinson's, Huntington's, brain tumor, seizure disorder, subdural hematoma, multiple sclerosis, brain lesion), untreated or insufficiently treated endocrine disorder, and/or treatment with investigational drug or intervention during the study period
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceNon-invasive form of brain stimulation.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Open-label aiTBS for pregnant/postpartum individualsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tolerability as measured by ratings of the Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 asks individuals about their overall experience with aTMS.Higher scores indicate a greater level of tolerability. We hypothesize that participants will report high levels of treatment satisfaction (\>24) on the Client Satisfaction Questionnaire (CSQ-8). The primary outcome will be a composite defined as meeting 3 out of 4 metrics listed here.
Time frame
1 month after treatment2
Acceptability as measured by percentage of individuals who complete an entire treatment course
Higher percentage of individuals who completed an entire course (i.e., 50 treatments) indicates higher acceptability. We hypothesize that 9/12 participants will complete at least 75% of treatments. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.
Time frame
1 month after treatment3
Safety as measured by reports of adverse events
We will monitor and report the rate of serious adverse events, including maternal seizures in the sample. We hypothesize that there will be no serious adverse events.
Time frame
1 month after treatment4
Feasibility as measured by the number of individuals treated throughout the study
Report of the number of individuals who received treatment throughout the entire study (i.e., approximately 2 years). We hypothesize that we will be able to enroll and treat 12 participants in two years. The primary outcome will be a composite defined as meeting 3 out of 4 metrics here.
Time frame
From the beginning to the end of the studySecondary outcomes
1
Montgomery-Åsberg Depression Rating Scale (MADRS)
A clinician rated tool used to assess the severity of depression in adults. The MADRS consists of 10 items, each scored on a 7 point scale 0-6 with higher scores indicating more severe depressive symptoms.
Time frame
From baseline to 1 month post treatment.2
Assess the effects of accelerated TMS on birth outcomes and lactation
We will monitor and report neonatal APGAR scores from infants delivered from mothers in the sample, birth weights, intradelivery maternal pain scores, birth modality (e.g. vaginal or C-section), and maternal blood loss. For individuals postpartum, we will ask participants to log their milk supply daily during treatment to determine any effects
Time frame
Throughout the 5 days of treatment to 1 month post treatmentOther outcomes
1
Beck Depression Inventory (BDI)
Depression severity rating scales (0-63, higher numbers indicate higher severity)
Time frame
Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment2
Beck Anxiety Inventory (BAI)
Anxiety severity rating scale (0-63, higher numbers indicate higher severity)
Time frame
Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment3
Young Mania Rating Scale (YMRS)
11 item scale evaluating mania. Scored 0-60. Higher score indicates worse outcome/higher mania
Time frame
Before treatment, daily throughout treatment, 2 week post treatment, and 1 month post treatment4
Edinburgh Postnatal Depression Scale
A scale created to help identify women who may be suffering from postpartum depression. Each question is scored 0-3, with a maximum score of 30. A score of more than 10 suggests minor or major depression may be present.
Time frame
Before treatment, 2 weeks after treatment, and 1 month after treatment.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov