Chronic PainEPR PainNCT06019793
Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain
A study testing DBS for Chronic Pain in people with Chronic Pain, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- DBS for Chronic Pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Barrow Neurological Institute
Phoenix, Arizona, 85013
About this study
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.
- Conditions
- Chronic Pain
- Being tested
- DBS for Chronic Pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS for Chronic PainDevice
Participants ill receive deep brain stimulation to relieve their chronic pain symptoms.
| Study group | Role | What they receive |
|---|---|---|
| DBS for Chronic Pain | Experimental | Not described Receives: Device: DBS for Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events
Measured: 2 years
Secondary outcomes (1)
Localized Brain Activity as Measured by Changes in LFP Activity in Relation to DBS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start11 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019793
- Sponsor's protocol ID
- 22-500-326-30-06
- Acronym
- EPR Pain
- Status last verified
- Nov 2024
- First submitted
- 22 Aug 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain
- ClinicalTrials.gov ID
- NCT06019793
- Acronym / sponsor ID
- EPR Pain / 22-500-326-30-06
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS for Chronic Pain | Experimental | Device: DBS for Chronic Pain |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS for Chronic PainParticipants ill receive deep brain stimulation to relieve their chronic pain symptoms. | Device | DBS for Chronic Pain |
Primary outcome
Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events
Time frame: 2 years
1 secondary outcome
Localized Brain Activity as Measured by Changes in LFP Activity in Relation to DBS
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
Recruiting
Rewiring the Chronic Pain Experience: Single-Session Model of Pain Reprocessing Therapy (PRT) at The Ottawa Hospital
Chronic Pain
Active, not recruiting
Effects of Subtalar Mobilization With and Without Foot Core Strengthening in Chronic Plantar Heel Pain
Chronic Plantar Heel Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS for Chronic Pain in people with Chronic Pain, run by St. Joseph's Hospital and Medical Center, Phoenix at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of DBS for Chronic Pain as Assessed by Incidence of Treatment-Related Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.