Status:
COMPLETED
EEG Synchronized TMS Trial for Depression
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Daily prefrontal TMS for depression, as developed by the PI, involves delivering TMS pulses to the prefrontal cortex and not assessing what the actual EEG phase is of the person's brain. In cardiology...
Detailed Description
The investigators have completed the first R21 phase of this combined two phase grant. Essentially, the investigators succeeded in creating for the first time on planet Earth a fully working combined ...
Eligibility Criteria
Inclusion
- Diagnosis of unipolar major depressive disorder, in a current major depressive episode, without psychotic features
- Pretreatment Hamilton score ≥ 20
- Age between 21 and 70 years
- Fixed and stable antidepressant medications for 3 weeks prior and during the rTMS trial. Limit on benzodiazapenes to lorazepam (or equivalent) up to 3 mg every day
- Moderate level of resistance to antidepressant treatment in the current episode, defined as failure of 1-4 adequate medication trials or intolerance to at least 3 trials, and duration of current episode ≤ 3 years
- No history of schizophrenia, schizoaffective disorder, other \[non mood disorder\] psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), bipolar disorder, psychotic features in this or previous episodes, amnestic disorder, dementia or MMSE ≤24, delirium, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder
- No current Vagus Nerve Stimulation
- No history of failing to respond to an adequate course of ECT in this or any episode, and no ECT within the past 3 months
- No contraindication to MRI
- No contraindication to rTMS (history of neurological disorder or seizure (except induced by ECT), increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 minutes, implanted electronic device, metal in the head, or pregnancy)
- No history of autoimmune, endocrine, viral, or vascular disorder. No unstable cardiac disease, uncontrolled hypertension, or sleep apnea
- No active suicidal intent or plan, or history of attempt within the past 12 months
- Willing to provide informed consent
Exclusion
- To ensure that baseline levels of depression severity are stable at the time of study enrollment, patients will be dropped if they show \> 30% improvement in the HRSD score from the time of initial intake (e.g., screening) to the baseline assessment.
- Patients must have a recordable alpha frequency.
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03421808
Start Date
November 30 2018
End Date
January 15 2024
Last Update
November 4 2025
Active Locations (1)
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1
Medical University of South Carolina Brain Stimulation Division
Charleston, South Carolina, United States, 29425