Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients
關鍵詞
抽象
描述
Will be included women aged between 18 and 65 years, chronic pain fibromyalgia according to the criteria of the American College of Rheumatology, pain unresponsive to analgesics such as paracetamol, acetylsalicylic acid, ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and Codeine. And give informed consent to participate after initial evaluation. Primary outcome is to evaluate the effect of treatment with home-base tDCS in patients with fibromyalgia. Secondary outcomes are: compare the effect of active home-based tDCS and sham in cortical neurophysiological processes and subcortical to stimulation with TMS and standardized noxious stimuli with and without concomitant conditioned Pain Modulation (CPM) in pain threshold outcomes to the test mechanical pressure, heat-algesic stimulus, cortical excitability parameters [evoked rest motor (MEP) MEP enough to evoke amplitude of 1 mV peak to peak, silent period (SP), motor threshold (MT), variation in blood volume and oxygenation cortical motor area [oxy-hemoglobin concentrations (Hbo) / deoxy-hemoglobin (HBr)] optically functional neuroimaging (NIRS) and variation in the frequency of alpha and beta waves of motor area stimulated by tDCS assessed by electroencephalogram (EEG). In surrogate outcome, the investigators will compare the effect of active home-sham tDCS the tDCS in pain levels and functional capacity, catastrophic thinking, bookmark levels of neurotrophic activity (BDNF) and astrocytic (S100 beta).
日期
最後驗證: | 07/31/2018 |
首次提交: | 10/27/2015 |
提交的預估入學人數: | 01/10/2016 |
首次發布: | 01/11/2016 |
上次提交的更新: | 07/31/2018 |
最近更新發布: | 08/02/2018 |
實際學習開始日期: | 12/31/2015 |
預計主要完成日期: | 04/30/2018 |
預計完成日期: | 06/11/2018 |
狀況或疾病
干預/治療
Other: Active-tDCs
Other: Sham-tDCS
相
手臂組
臂 | 干預/治療 |
---|---|
Active Comparator: Active-tDCs 17 patients will receive Active-tDCS intervention (2mA, 30 min) at home. | Other: Active-tDCs Active home-based tDCS applied at home. |
Sham Comparator: Sham-tDCS 17 patients will receive Sham-tDCS intervention (2mA, 30 min) at home. | Other: Sham-tDCS Sham home-based tDCS applied at home. |
資格標準
有資格學習的年齡 | 18 Years 至 18 Years |
有資格學習的性別 | Female |
接受健康志願者 | 是 |
標準 | Inclusion Criteria: - have chronic pain fibromyalgia according to the criteria of the American College of Rheumatology - Pain unresponsive to analgesics such as paracetamol, acetyl salicylic acid, Ibuprofen, Carisoprodol, Zanaflex (Tizanidine) and Codeine - Give informed consent to participate after initial evaluation. Exclusion Criteria: - Pregnancy - Treatment with carbamazepine and gabapentin - The. Metallic implant in the brain - Medical devices implanted in the brain - Alcohol or drug abuse history in the last 6 months - Suffering from severe depression (with score> 30 on the Beck Depression Inventory) - History of neurological disorders - Unexplained fainting History - History of head trauma or momentary loss of consciousness (self reported) - Neurosurgery History - Decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, renal failure and hepatitis). |
結果
主要結果指標
1. Pain level in fibromyalgia patients using home-based tDCS [Ffive days per week, during 12 weeks.]
次要成果指標
1. Serum levels of Brain Derived Neurotrophic Factor (BDNF) [2 days]
2. Serum levels of calcium-binding protein B (S100B) [2 days]
3. Functional capacity [2 days]
4. Catastrophic thinking [2 days]