Using Burst Deep Brain Stimulation to Treat Neuropathic Pain
Burst-Deep Brain Stimulation of the Thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a Prospective, Randomized Cross-over Feasibility Trial
This study is testing a new way of using brain stimulation to see if it can help people with chronic nerve pain feel better compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT05204472 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the effectiveness of Burst Deep Brain Stimulation (DBS) of the thalamus compared to traditional tonic DBS in reducing pain intensity in patients suffering from chronic neuropathic pain, specifically Central Post-stroke Pain (CPSP) and Neuropathic Facial Pain (NFP). The study involves implanting electrodes in the brain to deliver therapeutic electrical currents, utilizing a novel burst stimulation paradigm that has shown promise in spinal cord stimulation for pain relief. Participants will be monitored for changes in pain levels over time, providing insights into the efficacy of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with chronic unilateral neuropathic pain lasting over 12 months, resistant to standard pain medications.
Not a fit: Patients with significant cognitive impairments or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce chronic pain for patients suffering from neuropathic pain conditions, improving their quality of life.
How similar studies have performed: While burst stimulation has shown success in spinal cord stimulation, its application in deep brain stimulation for neuropathic pain is novel and has not been systematically evaluated before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Age 18-75 years * Patients suffering from chronic (duration \> 12 months) unilateral neuropathic pain caused by an ischemic or haemorrhagic cerebral stroke or * Patients suffering from chronic (duration \> 12 months) unilateral neuropathic facial pain due to one of the following causes: 1. post-herpes-zoster-neuralgia, 2. posttraumatic, neuropathic facial pain, 3. atypical trigeminal neuralgia after surgical intervention * Severe baseline pain intensity (VAS score \> 6/10) considered as resistant to medication specific to neuropathic pain at sufficient doses and durations (including at least antiepileptics and antidepressants) Exclusion Criteria: * Significant cognitive impairment (total MOCA score \< 1.5 standard deviations from age- and education adapted mean values), * DSMIV axis I or II psychiatric disorder * Relevant psychosocial risk factors (any of): history of other chronic pain syndrome, pain catastrophizing, substance abuse, secondary gain * Contra-indication to surgery, anesthesia, or MRI * Known or suspected non-compliance or inability to operate the DBS system * Woman with childbearing potential * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia. etc. of the subject * Participation in another interventional clinical trial within 30 days prior to this trial or during the trial * Previous enrollment into the current trial * Enrolment of the investigator's family members, employees, and other dependent persons * Patients who are planned to undergo diathermy, electroshock therapy or transcranial magnetic stimulation (TMS) * Patients with implanted electric devices (i.e. cardiac defibrillator, pacemaker) * Patients who are at poor surgical risk (i.e. patients with multiple severe illnesses or active general infections)
Where this trial is running
Bern
- Dep. of Neurosurgery, Bern University Hospital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Andreas Nowacki, MD — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Andreas Nowacki, MD
- Email: andreas.nowacki@insel.ch
- Phone: +41 31 6320014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.