Clinical trial NCT05204472: Thalamic-Burst-DBS for Neuropathic Pain
Official title: Burst-Deep Brain Stimulation of the Thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a Prospective, Randomized Cross-over Feasibility Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Post-stroke Pain
Neuropathic Pain
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke.

Recently, a modified stimulation paradigm has been developed in the field of spinal cord stimulation (SCS) for a variety of neuropathic pain disorders. To date, this stimulation paradigm has not yet been evaluated systematically for deep brain stimulation to treat neuropathic pain disorders.

The purpose of this clinical investigation is to investigate if Burst-DBS of the thalamus is more effective compared to classical continuous low-frequency stimulation DBS to reduce the subjective pain intensity in patients with chronic neuropathic pain after stroke or in patients with neuropathic facial pain.

Detailed description: Central post-stroke pain (CPSP) is a neuropathic pain syndrome and one of the major sequelae after ischemic or hemorrhagic cerebral stroke. Neuropathic facial pain (NFP) can arise after damage to or affection of the trigeminal nerve caused by trauma, infection or postsurgery and results in characteristic burning and shooting pain of the affected area in the face.

The lack of effective analgesic treatment for these two conditions continues to be an unmet medical need and led to the investigation of alternative treatments of CPSP and NFP such as deep brain stimulation (DBS). DBS is an invasive neuromodulation therapy that consists of placing small electrodes into confined anatomical structures of the brain to deliver small therapeutic currents.

Recently, a modified stimulation paradigm has been developed in the field of spinal cord stimulation (SCS) for a variety of neuropathic pain disorders. This so-called burst stimulation provides pulse trains of five high-frequency pulses at 500 Hz (= 500 Hz spike frequency) occurring 40 times a second (= 40 Hz burst frequency). Burst SCS has been demonstrated to provide a better pain relief compared to classical tonic (continuous application of 50 Hz stimulation) SCS without causing paresthesia. To date, this stimulation paradigm has not yet been evaluated systematically for deep brain stimulation to treat neuropathic pain disorders.

The purpose of this clinical investigation is to investigate if Burst-DBS of the thalamus is more effective compared to classical continuous low-frequency stimulation DBS to reduce the subjective pain intensity in patients with chronic neuropathic pain after stroke or in patients with neuropathic facial pain.

Eligibility 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)

Primary outcomes:
measure: Percentage reduction of pain intensity
timeFrame: 1 week after surgery
measure: Percentage reduction of pain intensity
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Change of pain intensity on the numeric rating scale
timeFrame: 12 months after surgery
measure: Percentage change of pain intensity on the Neuropathy pain scale
timeFrame: 12 months after surgery
measure: Percentage improvement of quality of life measured by the EuroQoL 5D-5L
timeFrame: 12 months after surgery
measure: Change of dosage of analgesic medication(s)
timeFrame: 12 months after surgery
measure: Efficacy of DBS
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Dep. of Neurosurgery, Bern University Hospital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Andreas Nowacki, MD
role: PRINCIPAL_INVESTIGATOR
References: