High Frequency rTMS for the Treatment of Neuropathic Pain in Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in pain severity
研究概览
简要总结
Tis study aims to assess whether multiple sessions of sham-controlled HF-rTMS applied to the motor cortex significantly reduces treatment-resistant neuropathic pain in diabetic patients.
This study will also investigate the effect of those rTMS sessions on functional connectivity of the M1 with brain areas involved in pain processing, underlying brain metabolism and brain plasticity using rs-fMRI, MRS and Paired-pulse stimulation respectively in those patients.
Subjects will be randomized into two groups to receive real or sham rTMS protocol. A washout period of at least 8 weeks will be respected between protocols to minimize carry-over effects. Sham stimulation will be delivered using a sham coil, providing the same auditory and sensory stimuli.
One daily rTMS session for 5 days of HF-rTMS, will be delivered through an H-coil applied to the primary motor area of the leg. Each session will last 20 minutes during which 30 consecutive trains of 50 stimuli will be delivered at 20 Hz at 100% of resting motor threshold (RMT), with an intertrain interval of 30s
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in this study is obtained
- •The subject is an out-patient aged 18 years or above with diabetes mellitus type 1 or 2
- •The patient has laboratory-confirmed diabetes
- •Patients are diagnosed with peripheral neuropathy based on clinical and electrophysiological findings
- •A score of > /= 4 on the the 'Douleur Neuropathique en 4 Questions' (DN4) questionnaire (30), conforming the diagnosis of neuropathic pain.
- •The patient has a painful diabetic neuropathy for at least 6 months
- •The patient has a Numeric pain rating scale (NPRS) score >/=
- •The patient is resistant to standard therapies for neuropathic pain
排除标准
- •The patient has an implanted cardiac device, such as a pacemaker or a defibrillator
- •The patient has an implanted neurostimulator
- •The patient has cochlear implants/ear implants, magnetic dental im-plants
- •The patient has a drug infusion pump
- •The patient has cerebral artery aneurysm clips
- •The patient has a history of epilepsy
- •The patient has a history of migraine or severe headaches
- •The patient has significant psychiatric disorders
- •For female patients: the subject is pregnant or lactating
- •Other formal contra-indication for rTMS or MRI
结局指标
主要结局
Changes in pain severity
时间窗: The NPRS will be controlled at following time points: prior to the initiation of the rTMS protocol, and then weekly until 2 months after the last treatment.
Neuropathic pain rating scale; Scores are based on patient responses to questions about pain intensity. 0 indicates no pain; 10 indicates the most pain imaginable
Changes in functional connectivity of the M1 with brain areas involved in pain processing
时间窗: rs-fMRI will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
rs-fMRI will be used
Changes in brain metabolism
时间窗: MRS will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
MRS will be used
Changes in brain plasticity
时间窗: Paired-pulse stimulation will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment
Paired-pulse stimulation will be used
次要结局
- influence on depression(Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment)
- influence on nerve conduction(this wil be controlled at baseline and 2 months after the last treatment.)
- Influence on the quality of life(Will be controlled at baseline before active or sham rTMS, 1 week after active rTMS and sham rTMS, 2 weeks after active and sham rTMS, 2 months after the last treatment)