Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients

August 1, 2018 updated by: Wolnei Caumo

Home-based Transcranial Direct Current Stimulation in Fibromyalgia Patients. Phase II, Randomized, Double-blind, Single-center Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90.450-120
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Wolnei Caumo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Ffive days per week, during 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 application of home-based tDCS
2 days
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
2 days
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.
2 days
Catastrophic thinking
Time Frame: 2 days
Measurement of catastrophic thinking pre and pos application of home-based tDCS with catastrophizing scale.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolnei Caumo

Investigators

  • Principal Investigator: Wolnei S Calmo, Ph.D, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

June 12, 2018

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

January 11, 2016

First Posted (ESTIMATE)

January 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0471

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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