Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S

NCT01984710 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: IRB000668435UH3NS103550
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment Resistant Depression

Keywords

Treatment Resistant Depression; Deep Brain Stimulation; Psychiatry; Neuro Surgery

Outcome Measures

Primary Outcomes (2)

• Changes in Activa PC+S Local Field Potential (LFP) Recordings

  Electrophysiological changes in response to stimulation will be quantified. Continuous Activa PC+S Local Field Potential (LFP) recordings will be monitored from Day 1 post-op until the battery is depleted, which is anticipated to be after approximately 2-3 years.

  From Day 1, up to 3 years

• Change in Hamilton Depression Rating Scale-17 Score

  The Hamilton Depression Rating Scale (HDRS-17) contains 17 items that are scored from 0 to 2, 3, or 4, where 0 is lack of difficulty and the highest number for an item is the most extreme difficulty. Total scores can range from 0 to 52 where higher scores represent greater symptom severity. Scores of 0-7 are considered normal, scores of 8-16 indicates mild depression, scores of 17-23 indicate moderate depression, and scores of 24 and greater indicate severe depression.

  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

Secondary Outcomes (24)

• Change in Hamilton Anxiety Rating Scale (HAM-A) Score

  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

• Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score

  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

• Change in Beck Depression Inventory (BDI-2) Score

  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

• Change in Beck Anxiety Inventory (BAI) Score

  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

• Change in Inventory of Depressive Symptomatology - Subject Rated (IDS-SR) Score

  Baseline; Recovery period with stimulation off: 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

Study Arms (1)

DBS for Treatment Resistant Depression

EXPERIMENTAL

DBS for TRD: Exploration of LFP with the Medtronic Activa PC+S "Brain Radio" system

Device: Medtronic Activa PC+S System

Interventions

Medtronic Activa PC+S System DEVICE

Also known as: Medtronic Inc

DBS for Treatment Resistant Depression

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 psychiatrist

You may not qualify if:

• Inability/ refusal to sign written informed consent
• 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

Sponsors & Collaborators

• Emory University: lead
• Hope for Depression Research Foundation: collaborator
• The Dana Foundation: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (3)

• Alagapan S, Choi KS, Heisig S, Riva-Posse P, Crowell A, Tiruvadi V, Obatusin M, Veerakumar A, Waters AC, Gross RE, Quinn S, Denison L, O'Shaughnessy M, Connor M, Canal G, Cha J, Hershenberg R, Nauvel T, Isbaine F, Afzal MF, Figee M, Kopell BH, Butera R, Mayberg HS, Rozell CJ. Cingulate dynamics track depression recovery with deep brain stimulation. Nature. 2023 Oct;622(7981):130-138. doi: 10.1038/s41586-023-06541-3. Epub 2023 Sep 20.

  PMID: 37730990 DERIVED

• Riva-Posse P, Crowell AL, Wright K, Waters AC, Choi K, Garlow SJ, Holtzheimer PE, Gross RE, Mayberg HS. Rapid Antidepressant Effects of Deep Brain Stimulation and Their Relation to Surgical Protocol. Biol Psychiatry. 2020 Oct 15;88(8):e37-e39. doi: 10.1016/j.biopsych.2020.03.017. Epub 2020 May 14. No abstract available.

  PMID: 32418613 DERIVED

• Veerakumar A, Tiruvadi V, Howell B, Waters AC, Crowell AL, Voytek B, Riva-Posse P, Denison L, Rajendra JK, Edwards JA, Bijanki KR, Choi KS, Mayberg HS. Field potential 1/f activity in the subcallosal cingulate region as a candidate signal for monitoring deep brain stimulation for treatment-resistant depression. J Neurophysiol. 2019 Sep 1;122(3):1023-1035. doi: 10.1152/jn.00875.2018. Epub 2019 Jul 17.

  PMID: 31314668 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Patricio Riva Posse, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Helen Mayberg, MD

  Emory University and Mount Sinai

  PRINCIPAL INVESTIGATOR

• Christopher Rozell, PhD

  Georgia Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: November 15, 2013
• Study Start: September 1, 2013
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: July 18, 2025

Record last verified: 2025-07

Locations

US (1)