Thalamic-Burst-DBS for Neuropathic Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
post-herpes-zoster-neuralgia,
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Burst DBS
DevicePatients 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).
Tonic DBS
DevicePatients 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).
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Burst DBS first, Tonic DBS secondExperimental treatment 2 interventions
Group B: Tonic DBS first, Burst DBS secondActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
1 week after surgery2
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
Time frame
2 weeks after surgerySecondary outcomes
1
Change of pain intensity on the numeric rating scale
Efficacy of DBS after 12 months of open-label stimulation measured as the percentage change of pain intensity on the numeric rating scale compared to baseline. Score 0-10 with 0 representing no pain, and 10 maximum pain intensity
Time frame
12 months after surgery2
Percentage change of pain intensity on the Neuropathy pain scale
Efficacy of DBS after 12 months of open-label measured as the percentage change of pain intensity on the Neuropathy pain scale (DN-4) compared to baseline. Score 0-10 with 0 representing no pain, and 100 maximum pain intensity
Time frame
12 months after surgery3
Percentage improvement of quality of life measured by the EuroQoL 5D-5L
Efficacy of DBS after 12 months of open-label measured as the percentage improvement of quality of life measured by the EuroQoL 5D-5L questionnaire (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/ Depression (rating from no problems to extreme problems) and health status self rating by patient (Score 0-100, 0 the worst health and 100 the best health)) compared to baseline.
Time frame
12 months after surgery4
Change of dosage of analgesic medication(s)
Change of dosage of analgesic medication(s) at 12 months of open-label stimulation measured as the total dosage in mg per medication per day with reference to baseline
Time frame
12 months after surgerySponsors and contacts
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Source ClinicalTrials.gov