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Closed-loop Deep Brain Stimulation to Treat Refractory Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT03029884
Recruitment Status : Active, not recruiting
First Posted : January 24, 2017
Results First Posted : November 22, 2023
Last Update Posted : November 22, 2023
Sponsor:
Collaborators:
United States Department of Defense
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Prasad Shirvalkar, MD, PhD, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Chronic Pain
Post Stroke Pain
Phantom Limb Pain
Spinal Cord Injuries
Interventions Device: Open-Loop DBS
Device: Sham Stimulation
Device: Closed-Loop DBS
Enrollment 4
Recruitment Details Recruitment was done through the UCSF Pain management clinic and online from clinicaltrials.gov from October 2017 to December 2019
Pre-assignment Details There was a 6 month run-in period for collection of personalized neural signals before stimulation began
Arm/Group Title Open vs Closed Loop vs Sham DBS
Hide Arm/Group Description Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in active DBS, blinded to the participant. Open-loop DBS refers to tonic stimulation of ACC or OFC regions without feedback control. Closed loop is feedback enabled stimulation triggered by pain biomarkers. Sham is no stimulation. Because >6 sequences were used, only 1 arm/group is defined as per instructions.
Period Title: Inactive DBS Run in Period (6 Months)
Started 4
Completed 4
Not Completed 0
Period Title: Open-Loop DBS (6 Weeks)
Started 4
Completed 4
Not Completed 0
Period Title: Closed-Loop DBS (6 Weeks)
Started 4
Completed 4
Not Completed 0
Period Title: Sham DBS (3 Weeks)
Started 4
Completed 4
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in active DBS, blinded to the participant.

Medtronic Activa PC+S: In Aim 2 we will perform closed loop DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. In Aim 3, closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
Chronic neuropathic pain with post stroke pain (3) or phantom limb pain (1)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
59
(56 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
4
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
Pain Intensity Numerical Rating Score   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 4 participants
7.95
(5 to 10)
[1]
Measure Description: Numerical Rating Score (NRS) ranges from 0 (no pain) to 10 (worst pain imaginable). Higher values indicate worse pain (worse outcome).
1.Primary Outcome
Title Visual Analog Score
Hide Description Visual Analog Score is indicated by the patient by marking a 10 cm line as they rate their pain intensity from 0 to 100 in mm. Higher scores represent worse outcome.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Inactive DBS Run in Period Open Loop DBS Closed Loop DBS Sham
Hide Arm/Group Description:
This period includes the DBS implant surgery, and a run in period of up to 6 months when brain signals are recorded, but electrical stimulation is not yet turned on.
Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in active DBS, blinded to the participant. Open-loop DBS refers to tonic stimulation of ACC or OFC regions without feedback control. Because >6 sequences were used, only 1 arm/group is defined as per instructions.
Closed loop is feedback enabled stimulation triggered by pain biomarkers.
Sham is no stimulation.
Overall Number of Participants Analyzed 4 4 4 4
Median (Full Range)
Unit of Measure: units on a scale (millimeters)
76
(50 to 100)
74
(22 to 100)
75
(50 to 100)
75
(61 to 100)
2.Secondary Outcome
Title Neuropathic Pain Questionnaire
Hide Description The Neuropathic pain Questionnaire (NPQ) is an assessment instrument for neuropathic pain intensity and quality. It contains 12 items: 10 related to sensations or sensory responses and two related to affect. The items are totaled and rated out of 12, with 12 being in the most neuropathic pain.
Time Frame 2 years
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Becks Depression Inventory
Hide Description The Becks Depression Inventory is commonly used assessment tools to quantify and track depression mood state over time. Its a single value outcome measurement ranging from 0 to 63, with 63 being the most depressed.
Time Frame 2 years
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Becks Anxiety Inventory
Hide Description The Becks Anxiety Inventory is commonly used assessment tools to quantify and track anxious mood state over time.Its a single value outcome measurement ranging from 0 to 63, with 63 the most anxious.
Time Frame 2 years
Outcome Measure Data Not Reported
5.Other Pre-specified Outcome
Title NIH PROMIS Toolbox (Patient Impression)
Hide Description

The NIH PROMIS toolbox contains a host of survey questions tailored to measurement of specific disease states such as pain, global health and function.

The patient impression evaluates patient self-evaluation and physician evaluation of the patient's general health ranging form 0 to 7 with 7 being the worst general health.
Time Frame 2 years
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Pain Medication Usage
Hide Description We will calculate total number of of breakthrough pain medication pills (eg. opioids, NSAIDs and neuropathic pain medication) used each month, to evaluate if analgesia from DBS reduces average usage.
Time Frame 2 years
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Activity Tracker (Fitbit) - Heartrate
Hide Description Each patient will be given a fitbit activity monitor which can record steps taken, flights of stairs climbed, heart rate and sleep quality. These measures will be used to infer functional improvement over time. Heartrate will be tracked as beats per minute (bpm) and the association of bpm with changes in NRS pain will be used to correlate changes in heartrate with pain levels.
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inactive DBS Run in Period Open Loop DBS Closed Loop DBS Sham
Hide Arm/Group Description This period includes the DBS implant surgery, and a run in period of up to 6 months when brain signals are recorded, but electrical stimulation is not yet turned on. Chronic brain recording and stimulation with unilateral or bilateral implantation in pain-related brain regions. Both thalamic pain syndrome and phantom pain participants will participate in active DBS, blinded to the participant. Open-loop DBS refers to tonic stimulation of ACC or OFC regions without feedback control. Because >6 sequences were used, only 1 arm/group is defined as per instructions. Closed loop is feedback enabled stimulation triggered by pain biomarkers. Sham is no stimulation.
All-Cause Mortality
Inactive DBS Run in Period Open Loop DBS Closed Loop DBS Sham
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)    
Hide Serious Adverse Events
Inactive DBS Run in Period Open Loop DBS Closed Loop DBS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      1/4 (25.00%)      0/4 (0.00%)      0/4 (0.00%)    
Nervous system disorders         
Hemorrhage †  1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0/4 (0.00%) 
Psychiatric disorders         
Suicidal Ideation (passive) †  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inactive DBS Run in Period Open Loop DBS Closed Loop DBS Sham
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      4/4 (100.00%)      1/4 (25.00%)      1/4 (25.00%)    
Nervous system disorders         
Headache †  4/4 (100.00%)  4 4/4 (100.00%)  7 0/4 (0.00%)  0 0/4 (0.00%)  0
Dizziness †  2/4 (50.00%)  2 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0
Fall †  1/4 (25.00%)  1 1/4 (25.00%)  3 0/4 (0.00%)  0 1/4 (25.00%)  1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prasad Shirvalkar MD, PhD - Principal Investigator
Organization: University of California, San Francisco
Phone: 415-885-7246
EMail: Prasad.Shirvalkar@ucsf.edu
Layout table for additonal information
Responsible Party: Prasad Shirvalkar, MD, PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03029884    
Other Study ID Numbers: 16-18617
UH3NS109556 ( U.S. NIH Grant/Contract )
First Submitted: January 6, 2017
First Posted: January 24, 2017
Results First Submitted: June 9, 2023
Results First Posted: November 22, 2023
Last Update Posted: November 22, 2023