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New treatment option for Central Post-stroke Pain
Official title Thalamic-Burst-DBS for Neuropathic Pain
ClinicalTrials.gov ID: NCT05204472
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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,
You likely can't join 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
See the full eligibility 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:
- 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)
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.