Alternating and Direct Current Stimulation for the Treatment of Chronic Neuropathic Eye Pain and Cerebral Symptoms: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month
研究概览
简要总结
The goal of this clinical intervention is to test if two forms of transcranial current stimulation, transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) can alleviate neuropathic eye pain in a sample of 20 patients.
The main aims are:
- Test if tDCS/tACS can alleviate neuropathic eye pain and/or other cerebral symptoms: brain fatigue, migraine, light sensitivity, etc.
- Test if one stimulation method is superior to the other Patients will be treated for a total of fifteen 30-minute stimulation sessions, three times a day over a five-day period, each stimulation separated by approximately 4 hours, with either active tACS or tDCS over the scalp corresponding to primary sensory and motor areas.
The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.
详细描述
Brief Summary sufficient
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •persistent eye pain for at least 6 months
- •average eye pain intensity of 4 or more on a 0-10 numerical rating scale
- •naive to transcranial stimulation
- •eye pain having neuropathic-like characteristics
排除标准
- •contraindication to transcranial stimulation (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy)
- •presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.)
- •current participation in another study with an investigational drug or device within one month prior to screening
研究组 & 干预措施
Transcranial alternating current stimulation
Transcranial alternating current stimulation (tACS) device using 50x70 mm electrodes that are placed bilaterally between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye). The alternating current electrodes are in-phase and have the same peak to peak stimulation 3mA, for 30 minutes duration at 10Hz. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.
干预措施: DC-Stimulator Plus (NeuroConn GmbH, Germany) (Device)
Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) device using 50x70 mm electrodes that has the anodal electrode placed contralateral to most prominent ocular pain or, in the case of bilateral pain symptoms, contralateral to the dominant hand between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye), and the cathode placed on the patient's upper arm. A current peaking at 3mA will ramp up for 20 secs and be delivered for a total of 20 minutes, thereafter, ramping down for 20s. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.
干预措施: Sooma direct current stimulator (Sooma, Finland) (Device)
结局指标
主要结局
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month
时间窗: through treatment completion, 1 month
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 month
时间窗: through treatment completion, 1 month
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline pupil diameter in millimeters at 1 week
时间窗: through treament completion, 1 week
Minimum and maximum pupil diameter in millimeters
Change from baseline pupil latency in milliseconds at 1 week
时间窗: through treament completion, 1 week
Pupil latency latency in milliseconds
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week
时间窗: through treatment completion, 1 week
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 2 weeks
时间窗: through treatment completion, 2 weeks
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 2 weeks
时间窗: through treatment completion, 2 weeks
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 week
时间窗: through treatment completion, 1 week
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month
时间窗: through treatment completion, 1 month
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Change from baseline pupil velocity in millimeters per second at 1 week
时间窗: through treament completion, 1 week
Pupil change velocity in millimeters per second
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 week
时间窗: through treatment completion, 1 week
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month
时间窗: through treatment completion, 1 month
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 2 weeks
时间窗: through treatment completion, 2 weeks
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 week
时间窗: through treatment completion, 1 week
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 2 weeks
时间窗: through treatment completion, 1 month
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire
时间窗: through treatment completion, 1 month
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
次要结局
- Treatment compliance rate(through study completion, 1 year)
研究者
Neil Lagali
Principal Investigator, Professor
Region Östergötland