Thalamic-Burst-DBS for Neuropathic Pain

NCT05204472 | Recruiting

• 1 other identifier: DBS for neuropathic pain
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Post-stroke Pain; Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Percentage reduction of pain intensity

  Percentage reduction of pain intensity on the numeric rating scale (NRS 1-10) after each stimulation-block compared to the baseline pain intensity before surgery. Score 0-10 with 0 representing no pain, and 10 maximum pain intensity

  1 week after surgery

• Percentage reduction of pain intensity

  Percentage reduction of pain intensity on the numeric rating scale (NRS 1-10) after each stimulation-block compared to the baseline pain intensity before surgery. Score 0-10 with 0 representing no pain, and 10 maximum pain intensity

  2 weeks after surgery

Secondary Outcomes (5)

• Change of pain intensity on the numeric rating scale

  12 months after surgery

• Percentage change of pain intensity on the Neuropathy pain scale

  12 months after surgery

• Percentage improvement of quality of life measured by the EuroQoL 5D-5L

  12 months after surgery

• Change of dosage of analgesic medication(s)

  12 months after surgery

• Efficacy of DBS

  12 months after surgery

Study Arms (2)

Burst DBS first, Tonic DBS second

EXPERIMENTAL

10 days of Burst-stimulation followed by 10 days of active tonic stimulation (Burst-DBS -\> tonic-DBS)

Device: Burst DBS; Device: Tonic DBS

Tonic DBS first, Burst DBS second

ACTIVE COMPARATOR

10 days of active tonic stimulation followed by 10 days of Burst-stimulation (tonic-DBS -\> Burst-DBS)

Device: Burst DBS; Device: Tonic DBS

Interventions

Burst DBS DEVICE

Patients undergo stereotactic implantation of DBS electrodes in the thalamus under local anesthesia. The DBS electrodes will be connected to an external pacemaker for a time period of four weeks. On the first day following surgery, patients will undergo an empirical clinical testing of the stimulation parameter settings. At the same day patients will undergo somatosensory- and contact heat-evoked potential recording for phenotype-stratification (post-hoc analysis).During the next 24 days with the electrodes externalized and connected to the external pacemaker, patients will be randomly assigned in a 1:1 ratio to one of the two groups that undergo two blocks of stimulation: 12 days of of Burst-stimulation followed by 12 days active tonic stimulation (Burst-DBS -\> tonic-DBS) Between each stimulation block the stimulator will be switched off for one day to prevent any hang-over effects of stimulation (wash-out period).

Burst DBS first, Tonic DBS second; Tonic DBS first, Burst DBS second

Tonic DBS DEVICE

Patients undergo stereotactic implantation of DBS electrodes in the thalamus under local anesthesia. The DBS electrodes will be connected to an external pacemaker for a time period of four weeks. On the first day following surgery, patients will undergo an empirical clinical testing of the stimulation parameter settings. At the same day patients will undergo somatosensory- and contact heat-evoked potential recording for phenotype-stratification (post-hoc analysis).During the next 24 days with the electrodes externalized and connected to the external pacemaker, patients will be randomly assigned in a 1:1 ratio to one of the two groups that undergo two blocks of stimulation: 12 days of active tonic stimulation followed by 12 days of Burst-stimulation (tonic-DBS -\> Burst-DBS) Between each stimulation block the stimulator will be switched off for one day to prevent any hang-over effects of stimulation (wash-out period).

Burst DBS first, Tonic DBS second; Tonic DBS first, Burst DBS second

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• post-herpes-zoster-neuralgia,
• posttraumatic, neuropathic facial pain,
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3000, Switzerland

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andreas Nowacki, MD

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Nowacki, MD

CONTACT

+41 31 6320014; andreas.nowacki@insel.ch

Söll Nicole

CONTACT

+41316323164; nicole.soell@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 24, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)