Trial record 11 of 129 for:    fibromyalgia | Open Studies | Interventional Studies

Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2016 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT02652988
First received: October 28, 2015
Last updated: January 11, 2016
Last verified: January 2016
  Purpose
In this phase II, randomized, double-blind clinical trial, the investigators intended to evaluate the home-based effect of transcranial direct current stimulation (tDCS) in patients with fibromyalgia. This syndrome affects between 3-5% of the population in an age group 40-60 years also occurring in childhood and old age. Reaches 3.4% of women and 0.5% of men. Fibromyalgia is a chronic widespread pain syndrome in various parts of the body. The neuromodulation techniques have as a principle produce inhibition or cortical arousal. The tDCS is a non-invasive brain stimulation method used to modulate the cortical excitability, using a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode electrodes. The current reaches the cortex, producing hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique able to alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, acute mania, bipolar affective disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after stroke, pain syndromes such as neuropathic pain, migraine, pancreatitis pain chronic and fibromyalgia. The tDCS is a low cost technique, with virtually no side effects and which exerts therapeutic effect by neuromodulatory pathways by distinct pathways activated by the drugs. In this scenario falls within the importance of developing this device for home use by fibromyalgia patients, since it is easy to use and thereby enables maintaining the benefit observed in studies performed and supervised frequently used in care centers. The use of tDCS over the long term is not feasible in hospital by patients demands, sometimes every day or more than once a week, removing the patient from their activities, and cost shifting and overload the healthcare system. Therefore, the objective of this study is to evaluate the effect of home-based tDCS in fibromyalgia patients in long-term treatment.

Condition Intervention Phase
Fibromyalgia
Other: Active-tDCS
Other: Sham-tDCS
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients. Phase II, Randomized, Double-blind, Single-center Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Pain level in fibromyalgia patients using home-based tDCS [ Time Frame: Ffive days per week, during 12 weeks. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Cortical excitability on the transcranial magnetic stimulation (TMS) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Measurement of serum levels of S100B pre and pos application of home-based tDCS

  • Functional capacity [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Measurement of catastrophic thinking pre and pos application of home-based tDCS with catastrophizing scale.


Estimated Enrollment: 32
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active-tDCs
17 patients will receive Active-tDCS intervention (2mA, 20 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, 20 min) at home.
Other: Sham-tDCS
Sham home-based tDCS applied at home.

Detailed Description:
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).
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02652988

Contacts
Contact: Wolnei Caumo, Ph.D wcaumo@cpovo.net
Contact: Aline Brietzke, MD aline_brietzke@yahoo.com.br

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
Principal Investigator: Wolnei S Calmo, Ph.D Hospital de Clínicas de Porto Alegre
  More Information

Publications:

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02652988     History of Changes
Other Study ID Numbers: 14-0471 
Study First Received: October 28, 2015
Last Updated: January 11, 2016
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
tDCS
chronic pain
fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2016