NeuroPace® RNS® System for Post Traumatic Stress Disorder

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post Traumatic Stress DisorderNeuroPace® RNS® System - Device
Eligibility
25 - 60
Male
What conditions do you have?
Select

Study Summary

This trial will use a device to record electrical activity in the brain to detect patterns associated with PTSD, which will then be treated with electrical pulses in an attempt to improve symptoms.

Eligible Conditions
  • Post Traumatic Stress Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

7 Primary · 25 Secondary · Reporting Duration: quarterly during year 2-4

12 months
Change in the PTSD symptoms as measures by the Clinician Administered PTSD Scale (CAPS)
Number of subjects with adverse events related to the use of responsive neurostimulation in PTSD.
change in the Montgomery Asberg depression rating scale
12 months post-operatively
Region of Interest analysis (FDG PET)
Baseline
Rey-15 Recognition test of Mental Effort
Wechsler Adult Intelligence Scale IV (WAIS-IV)
Month 6
Attention, Processing Speed and Memory: Wechsler Adult Intelligence Scale IV (WAIS-IV)143 - Digit Span subtest, Trail Making Test A and B, Ruff Figural Fluency Test (RFFT), Brief Visual Memory Test - Revised (BVMT-R), California Verbal Learning Test
Brief Visual Memory Test
California Verbal Learning Test
Controlled Oral Word Association (COWAT)
Digit Span subtest
Frontal Systems/ Executive Functions: Wisconsin Card Sorting Test (WCST), Stroop Color and Word Test, Iowa Gambling Task (IGT)
Hooper Visual Organization Test (VOT)
Iowa Gambling Task (IGT)
Montreal Cognitive Assessment (MOCA)
Revised (BVMT-R)
Rey-Osterrieth Complex Figure Test (CFT)
Ruff Figural Fluency Test (RFFT)
Stroop Color and Word Test
Trail Making Test A and B
Wechsler Test of Adult Reading
Wisconsin Card Sorting Test (WCST)
Month 48
Psychological scales (HAMA)
Psychological scales (MADRS)
Psychological scales (YBOC)
monthly after implantation for the first year
Clinician Administered PTSD Scale
quarterly during year 2-4
Alpha rhythm frequency (EEG)
Year 1
Tomography, Optical Coherence
Occurrence of adverse events
SF-36V (quality of life)
Source localization (EEG)
Spectral power analysis and oscillatory properties

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

RNS group
1 of 1

Experimental Treatment

6 Total Participants · 1 Treatment Group

Primary Treatment: NeuroPace® RNS® System · No Placebo Group · Phase < 1

RNS group
Device
Experimental Group · 1 Intervention: NeuroPace® RNS® System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: quarterly during year 2-4

Who is running the clinical trial?

University of California, Los AngelesOTHER
1,411 Previous Clinical Trials
6,941,559 Total Patients Enrolled
VA Greater Los Angeles Healthcare SystemLead Sponsor
46 Previous Clinical Trials
7,723 Total Patients Enrolled

Eligibility Criteria

Age 25 - 60 · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must be taking their current medication for at least 2 months before implantation and agree not to increase the dosage or add any new medications for the first 6 months of the study, unless it is medically necessary.
Stage 2 level of treatment resistance as per Sippel et al.136 refers to a clinical record that documents failure to respond to adequate (minimum 3 month, with adherence) trials of at least 3 of the following evidence-based treatments including at least one pharmacologic agent below, and at least one trauma-focused individual cognitive-behavior psychotherapy among the following: Pharmacologic: sertraline, paroxetine, fluoxetine or venlafaxine, at maximally tolerated FDA recommended doses
The person has had a minimum baseline past month CAPS-5 score of 47, with full PTSD diagnostic criteria met, and scores of ≥ 3 on at least one item from the intrusive (CAPS-5 items 1-5) and hyperarousal (CAPS-5 Items 15-20) clusters
PTSD is the most common diagnosis among people who experience chronic or treatment-refractory distress
Some patients who are unable to complete trauma-focused psychotherapy may be included in the study if they began treatment, but had to stop because the risks of continuing treatment outweighed the potential benefits.
All psychotherapy for PTSD that is backed by evidence must be completed at least three months before someone can enroll.
The man is between the ages of 25 and 60 years old.
The patient had the ability to give consent in accordance with institutional policies and participated in the 4-year follow-up, involving assessments and stimulator adjustments.
The study psychiatrist confirmed that PTSD was the primary psychiatric diagnosis after interviewing the patient and using the CAPS.
A person must have had a minimum of 5 years of illness, with no 6-month period of remission during the 2 years prior to study entry.

Who else is applying?

What state do they live in?
Washington33.3%
Georgia33.3%
Tennessee33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
VA Greater Los Angeles100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. VA Greater Los Angeles: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Phone Call100.0%