Using Burst Deep Brain Stimulation to Treat Neuropathic Pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Pain relief after stroke: spinal cord stimulation plus medicines vs medicines alone

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.