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Enrolling by invitationNCT06019793EPR PainUpdated Dec 9, 2024

Electrophysiological Recordings from Deep Brain Stimulation Electrodes for Pain

An interventional study of DBS for Chronic Pain in Chronic Pain, sponsored by St. Joseph's Hospital and Medical Center, Phoenix. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by St. Joseph's Hospital and Medical Center, Phoenix · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as enrolling by invitation.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Chronic Pain

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03

In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 50 is below the median of 60 across 2,161 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

St. Joseph's Hospital and Medical Center, Phoenix is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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.
  2. Patients that have been medically cleared for DBS surgery by the consensus committee.
  3. 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.
  4. Motorically and cognitively capable of completing evaluations and consent.
  5. Motorically and cognitively capable of participating in the study's computer-based tasks.
  6. Informed consent signed by the subject.
  7. Patient age between 22 to 75 years old.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    DBS for Chronic Pain

    Device: DBS for Chronic Pain

Interventions

  • DeviceDBS for Chronic Pain

    Participants ill receive deep brain stimulation to relieve their chronic pain symptoms.

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What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. Localized Brain Activity as Measured by Changes in LFP Activity in Relation to DBS

    Time frame: 2 years

07

Study locations

1 site
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06019793
Lead sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Responsible party
Sponsor
First posted
Aug 31, 2023
Start date
Jun 11, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 9, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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