NCT05487911
Cortical rTMS as a Treatment for Depression
Enrolling by Invitation
NAAges 18–64InterventionalTreatmentBaylor College of MedicineInvestigator-initiated
~50 participants
Updated 2024-06-04 on ClinicalTrials.gov
What's tested:Repetitive Transcranial Magnetic Stimulation
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Functional connectivity of orbital frontal cortex (OFC)
Measured over 20 days
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Be male or female aged 18-60 years old
Meets MDD criteria
Has depressive symptoms according to the Patients Health Questionnaire (PHQ)-9 or Hamilton Depression Rating Scale (HDRS) or Snaith-Hamilton Pleasure Scale (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
Has no contraindications to MRI (pacemaker, cochlear implants, metal in eyes, other metal implants, etc.); Meets the pre- screening MRI questions provided by the Center for Advanced MR Imaging (CAMRI)
Has no contraindications to TMS (any types of non-removable metal in their head except the mouth, or within 12 inches of the coil, etc.); Meets the pre-screening TMS safety questionnaire (Transcranial Magnetic Stimulation Adult Safety Screen - TASS)
Exclusion
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
Female subjects who are pregnant or nursing
Contraindications to MRI (pacemaker, cochlear implants, metal in the eye, other metal implants, etc.): Do not meet the pre-screening MRI questions provided by the CAMRI at BCM
Non-English speaking subjects (we do not have the staff and/or resources to include other language).
What this trial measures
- Functional connectivity of orbital frontal cortex (OFC)20 days
Functional connectivity of OFC changes after receiving TMS treatment
- Outcome Changes in MDD subjects20 days
The relationship between the functional connectivity changes and clinical outcome changes in MDD