Cortical rTMS as a Treatment for Depression

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorBaylor College of Medicine

About this trial

Depression is a leading cause of disability worldwide with a 19% lifetime prevalence in the United States. Dysfunctional reward processing is one of the core features of depression. Common treatments of depression include psychological therapies (e.g., cognitive behavioral therapy), medication (e.g., bupropion, sertraline) and psychological therapies and medication combined, but they may not address the function of the reward circuit in depression. These treatments often o not improve depressive symptoms in patients with depression who are classified as having treatment-resistant depression, and they may be unlikely to respond to further medication trials. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation that enables us to selectively excite or inhibit neural activity. Multiple TMS pulses given consecutively are known as repetitive TMS (rTMS), and the primary clinical location for applying rTMS is the left dorsolateral prefrontal cortex (DLPFC) for treatment of depressive symptoms. Many of these studies have shown that rTMS to the DLPFC may result in decreased depressive symptoms, but is only partially effective (response and remission rates of 41.2 and 35.3%, respectively). This evidence supports the importance of evaluating the efficacy of rTMS in other brain regions, such as the orbitofrontal cortex (OFC), in the treatment of depressive symptoms rather than in the DLPFC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be male or female aged 18-64 years old.

Has depressive symptoms according to the PHQ-9 or MADRS or HDRS or SHAPS

Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures

Female subjects must be non-nursing and not pregnant at the times of fMRI experiments and TMS treatment

Disqualifiers

In the opinion of the clinician and/or the research team, be expected to fail to complete the study protocol due to not tolerable to receive TMS

Unable to understand the design and requirements of the study;

Unable to sign informed consent for any reason

Has an unstable medical condition, including AIDS, acute hepatitis, active TB, unstable cardiac disease, unstable diabetes, hepatic or renal insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    Device

    1. 4 weeks of active rTMS (total of up to 20 sessions) 2. 5 sessions per day for 5 consecutive days (total of up to 25 sessions)

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: rTMSExperimental treatment 1 intervention
Group B: Accelerated TMSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Functional connectivity of orbital frontal cortex (OFC)

Functional connectivity of OFC changes after receiving TMS treatment

Time frame
20 days or 5 days
2

Clinical outcomes

Clinical outcomes include depressive symptoms, craving symptoms, and suicidal behaviors

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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