Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
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|ClinicalTrials.gov Identifier: NCT02046330|
Recruitment Status : Recruiting
First Posted : January 27, 2014
Last Update Posted : March 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Treatment Resistant Depression||Device: Deep Brain Stimulation Model 3387 Model 3389||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation (DBS) Therapy for Treatment Resistant|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: Deep Brain Stimulation
Device implantation (Deep Brain Stimulation Model 3387 Model 3389)
Device: Deep Brain Stimulation Model 3387 Model 3389
Implantation of all devices will be performed at a single session. Lead implantation will take place under local anesthesia, with implanted pulse generator (IPG) implantation under general anesthesia. The stereotaxic frame will be fitted on the day of surgery, following standard stereotactic surgical procedure. The leads will be inserted so that the stimulation sites span superolateral median forebrain bundle.
Other Name: Medtronic Neuromodulation
- Changes in patients MADRS scores [ Time Frame: weekly (24 Months) ]We will assess individual patient response, measured by standardized patient and clinician ratings of depression severity, under blinded conditions. Prospective ratings using validated and reliable measures of symptoms, quality of life and safety will be employed. We will assess safety for all subjects by monitoring any adverse events.
- Accuracy of Electrode placement [ Time Frame: Post-operation (weekly for 24 months) ]We will implant the Model 3387/Model 3389 lead at this target location, with the exact choice of lead to be determined during surgery.
- Frequency and Charge of Stimulation [ Time Frame: Weekly (24 months total) ]The optimal stimulation parameters for reducing depressive symptoms acutely and chronically are unknown. Preliminary data suggest that psychiatric patients who have responded to DBS have responded at high frequencies and amplitudes that presumably induce a depolarization block or "neuronal jamming," and thus mimic a lesion. We intend to explore the effects of a wide range of frequencies and amplitudes during the acute testing phase and to utilize high frequency continuous stimulation at the lowest amplitude that results in a definitive effect in the chronic phase of the study.
- Determine Feasibility of a Double Blind Study [ Time Frame: 24 months ]We hypothesize that it will be possible to develop a suitable double-blind procedure by which neither patients nor physicians will know whether DBS is on or off at any given moment.
- Decrease in Neurocognitive scores on CSTC [ Time Frame: pre-operative, 12 month and 24 months post-operation ]In this study, neuropsychological tests believed sensitive to changes in Concept Shifting Test-Combined (CSTC) function, and particularly orbitofrontal function, will be obtained with the stimulator on and off, if possible, under blinded conditions. In a separate study, positron emission tomography (PET) perfusion imaging and neuropsychological tests will be obtained to determine how corticobasal brain function changes after acute and chronic DBS.
- Assess maintenance of treatment response (or remission) associated with chronic DBS: [ Time Frame: 6, 12, and 24 months ]Maintaining Treatment Response
- Number of Adverse Events [ Time Frame: 24 months (reported weekly) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046330
|Contact: Jair C Soares, MD, PhDemail@example.com|
|Contact: Giovana Zunta-Soares, MDfirstname.lastname@example.org|
|United States, Texas|
|UT Center of Excellence on Mood Disorders||Recruiting|
|Houston, Texas, United States, 77054|
|Contact: Kathryn Durkin, BS 713-486-2627 email@example.com|
|Contact: Giovana Zunta-Soares, MD 713-486-2629 firstname.lastname@example.org|
|Principal Investigator: Jair C Soares, MD|
|Principal Investigator:||Jair C Soares, MD, PhD||The University of Texas Health Science Center, Houston|