Burst-Deep Brain Stimulation of the Thalamus for Neuropathic Facial Pain and Central Poststroke Pain: a Prospective, Randomized Cross-over Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage reduction of pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Burst DBS first, Tonic DBS second
10 days of Burst-stimulation followed by 10 days of active tonic stimulation (Burst-DBS -> tonic-DBS)
干预措施: Tonic DBS (Device)
Burst DBS first, Tonic DBS second
10 days of Burst-stimulation followed by 10 days of active tonic stimulation (Burst-DBS -> tonic-DBS)
干预措施: Burst DBS (Device)
Tonic DBS first, Burst DBS second
10 days of active tonic stimulation followed by 10 days of Burst-stimulation (tonic-DBS -> Burst-DBS)
干预措施: Burst DBS (Device)
Tonic DBS first, Burst DBS second
10 days of active tonic stimulation followed by 10 days of Burst-stimulation (tonic-DBS -> Burst-DBS)
干预措施: Tonic DBS (Device)
结局指标
主要结局
Percentage reduction of pain intensity
时间窗: 2 weeks after surgery
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
Percentage reduction of pain intensity
时间窗: 1 week after surgery
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
次要结局
- Change of dosage of analgesic medication(s)(12 months after surgery)
- Efficacy of DBS(12 months after surgery)
- 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)