Repetitive transcranial magnetic stimulation of the precentral-gyrus in the relief of fibromyalgia pain: an international multicenter controlled adaptive trial - TMSFFI

Kishima Haruhiko0 个研究点目标入组 10 人开始时间: 2019年12月23日最近更新: 2024年1月22日

适应症

试验速览

暂无简介。

•(1) Female patients with diagnosis fibromyalgia according to the ACR 2016 criteria (patient satisfies modified 2016 fibromyalgia criteria if the following 3 conditions are met
•i) widespread pain index (WPI) >= 7 and symptom severity scale (SSS) score >= 5 or WPI of 3-6 and SSS score >= 9.
•ii) Generalized pain, defined as pain in at least 4 of 5 regions, must be present. Jaw, chest, and abdominal pain are not included in generalized pain definition.
•iii) Symptoms have been generally present for at least 3 months.
•(2) Persistent pain for more than 6 months before enrollment.
•(3) Stable treatment for atleast 2 months before enrollment and throughout the study.
•(4) Age of 20 to 80 years.
•(5) Right-handed patients.
•(6) Be able to understand study protocol and give signed, written informed consent.
•(7) NRS score >= 4/10

•(1) Known abuse of alcohol or illicit drugs
•(2) Known psychiatric conditions (DSM-V)
•(3) Contraindications to rTMS (Head trauma or concussion, metal implants in the skull, cardiac pacemaker, medication infusion devices, previous troubles with TMS or MRI)
•(4) Pregnancy or breastfeeding
•Being under chronic contraceptive use (intrauterine dispositive or oral contraceptive)
•(5) Other medical conditions demand hospitalization;
•(6) Participation in other clinical studies at the same time
•(7) Use of strong opioids
•(8) Transcranial magnetic stimulation-naive
•(9) Inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound the assessment of fibromyalgia pain
•(10) On medications known to increase the risk of TMS-induced seizures (eg, theophylline, Ritalin, high-dose thyroid supplementation)
•(11) If they had medication changes within 4 weeks of starting the trial or during the trial
•(12) Neurologic disorders
•(13) If they had stroke, bipolar disorder, or schizophrenia

发起方

Kishima Haruhiko