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Electrophysiological Recordings From Deep Brain Stimulation Electrodes for Pain (EPR Pain)

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
DBS for Chronic Pain
Sponsored by
St. Joseph's Hospital and Medical Center, Phoenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who have intractable pain, as defined by: chronic (>1 year), severe (VAS score > 6/10), and persistent (not responsive to medication or relevant surgical options) without cognitive impairment or comorbidities affecting surgical risk. Patients that have been medically cleared for DBS surgery by the consensus committee. Not exhibiting significant distress, anxiety, or psychological disturbance that may be worsened due to externalized leads or potential complications or by study recording or tasks. Motorically and cognitively capable of completing evaluations and consent. Motorically and cognitively capable of participating in the study's computer-based tasks. Informed consent signed by the subject. Patient age between 22 to 75 years old. Exclusion Criteria: Patients that are not a candidate for DBS. This may occur for example, if they are unable to properly operate the neurostimulator. Also, several medical procedures and studies are not compatible with DBS. These include diathermy, transcranial magnetic stimulation, MRI procedures using radio-frequency coils, electroconvulsive therapy. Patients are receiving these treatments or plan to receive them in the future will not be eligible. Also, the safety of DBS has not been established for patients with a previous surgical ablation, dementia, coagulopathies, moderate to severe depression, or patients who are pregnant. Patients with these conditions will also not be eligible. Finally, DBS may be affected by or may affect other medical devices including cardiac pacemakers/defibrillator, ultrasonic equipment, radiation therapy, and incomplete (abandoned) prior DBS systems. Patients with these conditions/devices will not be eligible for the study. Subjects who have pain that is not severe enough to be considered for DBS: shorter than 1 year duration, VAS score < 6/10), responsive to medication or relevant surgical options. Subjects deemed to have a psychiatric illness that would potentially interfere or cause undue stress during the awake implantation surgery, the 1-3 week stimulation trial period, or the long term care of the DBS system are ineligible to undergo the DBS implantation procedure and thus would not be able to participate in this trial.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    DBS for Chronic Pain

    Arm Description

    Outcomes

    Primary Outcome Measures

    Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events

    Secondary Outcome Measures

    Localized Brain Activity in Relation to DBS Effect

    Full Information

    First Posted
    August 22, 2023
    Last Updated
    August 25, 2023
    Sponsor
    St. Joseph's Hospital and Medical Center, Phoenix
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06019793
    Brief Title
    Electrophysiological Recordings From Deep Brain Stimulation Electrodes for Pain
    Acronym
    EPR Pain
    Official Title
    Electrophysiological Recordings From Deep Brain Stimulation Electrodes for Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    St. Joseph's Hospital and Medical Center, Phoenix

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Over the last 30 years, deep brain stimulation (DBS) has allowed tens of thousands of patients to receive relief of neurological symptoms that were refractory to standard medical treatment. Furthermore, by providing a rare window into the electrophysiological activity of the awake, human brain, DBS has facilitated invaluable advances in scientific understanding. These advances have then, in turn, allowed for further therapies to be developed for an ever growing population of patients that benefit from DBS therapy. This study hopes to add to this growing body of knowledge by implanting leads within, and recording from, the sensory thalamus and periaqueductal gray (PAG) in patients with chronic pain. Specifically, we hope to establish the long-term safety of DBS leads within the periaqueductal gray and sensory thalamus for the treatment of chronic pain. Furthermore, by recording from the electrodes of DBS patients implanted for treatment of their chronic pain, we hope to understand how the pain network responds to sensory stimuli and how DBS changes this response.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    DBS for Chronic Pain
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    DBS for Chronic Pain
    Intervention Description
    Participants ill receive deep brain stimulation to relieve their chronic pain symptoms.
    Primary Outcome Measure Information:
    Title
    Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Localized Brain Activity in Relation to DBS Effect
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients who have intractable pain, as defined by: chronic (>1 year), severe (VAS score > 6/10), and persistent (not responsive to medication or relevant surgical options) without cognitive impairment or comorbidities affecting surgical risk. Patients that have been medically cleared for DBS surgery by the consensus committee. Not exhibiting significant distress, anxiety, or psychological disturbance that may be worsened due to externalized leads or potential complications or by study recording or tasks. Motorically and cognitively capable of completing evaluations and consent. Motorically and cognitively capable of participating in the study's computer-based tasks. Informed consent signed by the subject. Patient age between 22 to 75 years old. Exclusion Criteria: Patients that are not a candidate for DBS. This may occur for example, if they are unable to properly operate the neurostimulator. Also, several medical procedures and studies are not compatible with DBS. These include diathermy, transcranial magnetic stimulation, MRI procedures using radio-frequency coils, electroconvulsive therapy. Patients are receiving these treatments or plan to receive them in the future will not be eligible. Also, the safety of DBS has not been established for patients with a previous surgical ablation, dementia, coagulopathies, moderate to severe depression, or patients who are pregnant. Patients with these conditions will also not be eligible. Finally, DBS may be affected by or may affect other medical devices including cardiac pacemakers/defibrillator, ultrasonic equipment, radiation therapy, and incomplete (abandoned) prior DBS systems. Patients with these conditions/devices will not be eligible for the study. Subjects who have pain that is not severe enough to be considered for DBS: shorter than 1 year duration, VAS score < 6/10), responsive to medication or relevant surgical options. Subjects deemed to have a psychiatric illness that would potentially interfere or cause undue stress during the awake implantation surgery, the 1-3 week stimulation trial period, or the long term care of the DBS system are ineligible to undergo the DBS implantation procedure and thus would not be able to participate in this trial.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Markey Olson, MS
    Phone
    4802660913
    Email
    markey.olson@dignityhealth.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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