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临床试验/NCT04165980
NCT04165980已完成不适用

Effects of Non-invasive Brain Stimulation Methods in Experimentally Induced Pain

Aalborg University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Corticomotor excitability

研究概览

简要总结

Corticomotor excitability, pain sensitivity, descending pain control and somatosensory evoked potentials (SEPs) is often altered in acute and chronic pain.

Topical capsaicin generates stable, long-lasting hyperalgesia and ongoing tonic pain in healthy participants, which significantly inhibits corticomotor excitability in the primary motor cortex (M1).

Recent studies (by Fischer et al 2017) indicated that multifocal Transcranial Direct Current Stimulation (tDCS) administered to brain regions linked to the resting state motor network (network-tDCS) could enhance corticomotor excitability in healthy participants compared to single site M1-tDCS.

It remains unknown whether network-tDCS has also the potential to modulate the inhibitory effects on motor cortex excitability, pain sensitivity, descending pain control and SEPs associated with prolonged pain

详细描述

To date, pain modulation to M1 rs-network tDCS during 8% capsaicin induced pain has not been assessed (Mylius, Borckardt and Lefaucheur, 2012). Further, it is unknown how multichannel tDCS acts on tonic cutaneous pain for approximately 24 hours.

The main objective of these projects are to study and characterize quantitatively the effects of multichannel tDCS in the development of prolonged pain.

It is hypothesized that multichannel tDCS of left M1 resting-state network will reduce the severity of experimentally prolonged pain over the m. first dorsal interosseous (FDI), will increase descending pain control, might possibly increase pain thresholds and simultaneously will modulate the peak-to-peak amplitude of SEPs to electrical painful stimulation. Further, it is hypothesized that descending pain modulation of M1 tDCS will be related to interference with the suppression of cortical excitability

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Right-handed healthy men and women in the age 21-50 years who speak and understand English

排除标准

  • Lack of ability to cooperate
  • History of chronic pain or current acute pain
  • Pregnancy
  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Present and previous neurologic, musculoskeletal or mental illnesses
  • Chili allergies (subproject 1 and 2)
  • Current use of medications that may affect the trial
  • Previous experience with rTMS and tDCS
  • Contraindications to rTMS application (history of epilepsy, metal implants in head or jaw, etc.)
  • Failure to pass the questionnaire for tDCS
  • Failure to pass the "TASS questionnaire" (TASS = Transcranial Magnetic Stimulation Adult Safety Screen) (Rossi et al., 2001)

结局指标

主要结局

Corticomotor excitability

时间窗: 24 hours

Corticomotor excitability is expressed as the peak-to-peak amplitude of motor evoked potentials to single-pulse transcranial magnetic stimulation. It is expected that network-tDCS will reduce corticomotor inhibition induced by tonic pain during 24 hours.

次要结局

  • Warm detection thresholds (sensitivity measure)(24 hours)
  • Heat pain thresholds (pain sensitivity measure)(24 hours)
  • Mechanical pain thresholds (pain sensitivity measure)(24 hours)
  • Amplitude of SEPs to electrical painful stimulation(24 hours)
  • Cuff pressure pain sensitivity(24 hours)
  • Conditioned pain modulation effect(24 hours)
  • Latency of SEPs to electrical painful stimulation(24 hours)

研究者

发起方
Aalborg University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luisina Gregoret

PhD Fellow

Aalborg University

研究点 (2)

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