Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S (NCT01984710) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S
United States10 participantsStarted 2013-09
Plain-language summary
The goal of this study is to use the Activa Primary Cell + Sensing (PC+S) device to study Latent Field Potential (LFP) in the brains of people with Treatment Resistant Depression (TRD) before and during active stimulation. The ultimate goal is to understand the neural network that causes TRD and the changes that DBS cause in that network that results in the antidepressant effects.
Who can participate
Age range
25 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Ability to provide written informed consent.
* Agrees to relocate to the Atlanta Metro region for the duration of the acute phase of the investigation (approximately 8-10 months) and to return regularly for clinical and research assessments
* Current Major Depressive Episode (MDE), either Major Depressive Disorder single episode or recurrent type
* Current depressive episode of at least two years duration or a history of more than 4 lifetime depressive episodes
* Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17)
* Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score
* A maximum Global Assessment of Functioning of 50 or less
* Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different drug classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode
* Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode
* On stable antidepressant medication
* Have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Activa PC+S Local Field Potential (LFP) Recordings
Timeframe: From Day 1, up to 3 years
2
Change in Hamilton Depression Rating Scale-17 Score
Timeframe: Baseline; Recovery period with stimulation off: 24 hours post-operative, Weeks 1, 2, 3, 4; Stimulation phase: every 1-2 weeks up to week 30; Naturalistic follow up: every 1 to 6 months for up to 10 years