We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

DBS for TRD Medtronic Activa PC+S

This study is currently recruiting participants.
Verified November 2017 by Helen Mayberg, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01984710
First Posted: November 15, 2013
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Hope for Depression Research Foundation
The Dana Foundation
Information provided by (Responsible Party):
Helen Mayberg, Emory University
  Purpose
Major depressive disorder is a common disease. For many people, conventional treatments such as antidepressants are very helpful in relieving the symptoms of this condition. But as many as 30% of patients with depression have less than a full response or become resistant to conventional treatments. When treatment resistance develops, the depression becomes a chronic disease with a very significant burden of morbidity and mortality. The reasons that some patients develop Treatment Resistant Depression (TRD) are not known. One current theory for depression is that it results from the dysfunction of a network of regions in the brain and that in treatment resistant patients the network is permanently stuck in the dysfunctional state. We have been investigating an experimental treatment for treatment resistant depression (TRD), based on this network theory known as subcallosal deep brain stimulation (SCC DBS). This treatment involves placement of electrodes in a specific region of the brain (subcallosal cingulate cortex, area 25) and then stimulating that area with electricity, which resets the regulation of the network resulting in a significant antidepressant response. While still experimental our results suggest this may eventually be a useful treatment for some patients with TRD. The experiment described in this application is to use a new DBS device that can record the electrical activity in the brain around the site of stimulation. The electrical activity is known as Latent Field Potential (LFP) and is a reflection of the activity if the neural network. The new DBS device is an experimental device that has not been approved by the Food and Drug Administration (FDA), but allows for simultaneous recording of LFP while stimulation is being delivered. The device is manufactured by Medtronics and is known as Activa Primary Cell + Sensing(PC+S), but because it can be used to record the brain electrical activity it is also known as "the Brain Radio". The Brain Radio is based on an approved device commonly used for DBS for other conditions that has the added sensor capacity. The stimulation system is identical to that in the approved device. The goal of this investigation is to use the Brain Radio to study LFP in the brains of people with 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. We will recruit 10 patients with advanced TRD and implant them with the Brain Radio system. The recording system will be to record LFP over 3 years, while patients receive stimulation. A brief discontinuation study will be conducted after 6 months of stimulation when the device will be turned off and patterns of LFP changes will be recorded. All LFP measures will be correlated with the primary clinical response outcome metric, the Hamilton Depression Rating Scale. The knowledge gained with this experiment will be invaluable to understanding the basic pathology of depression and the antidepressant response. This is a unique, first in humans test of this device and as such the results are expected to impact our understanding of depression at a fundamental basis.

Condition Intervention
Treatment Resistant Depression Device: Medtronic Activa PC+S System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Treatment Resistant Depression: Exploration of Local Field Potentials (LFP) With the Medtronic Activa Primary Cell + Sensing (PC+S) "Brain Radio" System

Further study details as provided by Helen Mayberg, Emory University:

Primary Outcome Measures:
  • Activa PC+S LFP recordings [ Time Frame: Up to 3 years ]
    Activa PC+S LFP recordings. Continuous LFPs from SCC25 will be the primary dependent measure sampled throughout the study. Clinical outcome will be measured using the Hamilton Depression Rating Scale (HDRS) (17 item). Both the LFP and HDRS and Activa PC+S will be measured weekly for 4 weeks then weekly or biweekly for the next 3 months and monthly for 3 months every 3 months for 9 months then 6 month -12 months for 10 years. When the Activa PC+S battery is depleted which is anticipated to be after approximately 2-3 years there will be no more Activa PC+S outcome measures.


Estimated Enrollment: 20
Study Start Date: September 2013
Estimated Study Completion Date: September 2023
Estimated Primary Completion Date: September 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DBS for Treatment Resistant Depression
DBS for TRD: Exploration of LFP with the Medtronic Activa PC+S "Brain Radio" system
Device: Medtronic Activa PC+S System
Other Name: Medtronic Inc

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 25-70 years old.
  • 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 depressive episode of at least two years duration OR a history of more than 4 lifetime depressive episodes.
  • 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
  • All patients must have an established outpatient psychiatrist and be willing to sign a written release to allow study investigators to give and receive information from this psychiatrist.

Exclusion Criteria:

  • Refusal or inability to relocate to Atlanta Metro region for acute phase of protocol or to return for regular assessments in long term follow up
  • Inability to tolerate general anesthesia.
  • Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurological disorder.
  • Other currently active clinically significant Axis I psychiatric diagnosis including bipolar disorder, schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder.
  • Current psychotic symptoms.
  • Evidence of global cognitive impairment.
  • Substance abuse or dependence not in full, sustained remission.
  • Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years.
  • Pregnancy or plan to become pregnant during the study period.
  • General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices).
  • Inability or unwillingness to comply with long-term follow-up.
  • History of intolerance to neural stimulation of any area of the body.
  • Participation in another drug, device or biologics trial within the preceding 30 days prior to initial screening.
  • Conditions requiring repeated MRI scans.
  • Conditions requiring diathermy.
  • Conditions requiring anticoagulant medication.
  • Terminal illness associated with expected survival of <12 months.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01984710


Contacts
Contact: Sinead Quinn 404-727-9228 scquinn@emory.edu
Contact: Lydia Denisson 404-712-1580 dbs@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Hope for Depression Research Foundation
The Dana Foundation
Investigators
Principal Investigator: Helen Mayberg, MD Emory University
  More Information

Responsible Party: Helen Mayberg, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01984710     History of Changes
Other Study ID Numbers: IRB00066843
First Submitted: September 23, 2013
First Posted: November 15, 2013
Last Update Posted: November 6, 2017
Last Verified: November 2017

Keywords provided by Helen Mayberg, Emory University:
Treatment Resistant Depression
Deep Brain Stimulation
Psychiatry
Neuro Surgery

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders