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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|