Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients
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|ClinicalTrials.gov Identifier: NCT02652988|
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Other: Active-tDCS Other: Sham-tDCS||Not Applicable|
|Study Type :||Interventional|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients. Phase II, Randomized, Double-blind, Single-center Clinical Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Active-tDCs
17 patients will receive Active-tDCS intervention (2mA, 20 min) at home.
Active home-based tDCS applied at home.
Sham Comparator: Sham-tDCS
17 patients will receive Sham-tDCS intervention (2mA, 20 min) at home.
Sham home-based tDCS applied at home.
- Pain level in fibromyalgia patients using home-based tDCS [ Time Frame: Ffive days per week, during 12 weeks. ]Evaluate the level of pain in fibromyalgia patients before and after each home-based tDCS session. We will use numerical pain scale to do that.
- Cortical excitability on the transcranial magnetic stimulation (TMS) [ Time Frame: 2 days ]Evaluation of the variation in cortical excitability parameters pre and pos application of home-based tDCS
- Serum levels of Brain Derived Neurotrophic Factor (BDNF) [ Time Frame: 2 days ]Measurement of serum levels of BDNF pre and pos application of home-based tDCS
- Serum levels of calcium-binding protein B (S100B) [ Time Frame: 2 days ]Measurement of serum levels of S100B pre and pos application of home-based tDCS
- Functional capacity [ Time Frame: 2 days ]Measurement of functional capacity pre and pos application of home-based tDCS with functional capacity scale in chronic pain.
- Catastrophic thinking [ Time Frame: 2 days ]Measurement of catastrophic thinking pre and pos application of home-based tDCS with catastrophizing scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652988
|Contact: Wolnei Caumo, Ph.Demail@example.com|
|Contact: Aline Brietzke, MDfirstname.lastname@example.org|
|Hospital de Clinicas de Porto Alegre||Recruiting|
|Porto Alegre, Rio Grande do Sul, Brazil, 90.450-120|
|Contact: Wolnei Caumo, PhD +5551 3359 8083 email@example.com|
|Principal Investigator: Wolnei Caumo, PhD|
|Porto Alegre, Rio grande do Sul, Brazil|
|Contact: Aline Brietzke, PhD 5551 996097850|
|Principal Investigator:||Wolnei S Calmo, Ph.D||Hospital de Clínicas de Porto Alegre|