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Clinical Trials/NCT02993952
NCT02993952CompletedNot Applicable

Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever

Universidade Federal do Rio Grande do Norte1 site in 1 country20 target enrollmentStarted: December 12, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Change from baseline Pain at 3 weeks

Study Overview

Brief Summary

One of the major challenges faced by researchers working in the field of rehabilitation science is the ability to provide integrative approaches to the use of clinical practice. In this context it becomes increasingly necessary to construct investigative approaches, so that they can reach clinical practice in a shorter period of time,since the large volume of information produced globally does not impact in the short or medium term on new therapeutic recommendations. Among the various chronic painful entities, there is chikungunya fever as a highlight for having a rich clinical chronology in relation to pain. Its therapy is used done by drugs in almost all national and international consensuses, therefore therapy against pain in chikungunya fever is limited during the rehabilitation process. It is very important that the science of rehabilitation enhances methods of noninvasive brain modulation that enable, through the excitation or inhibition of specific cortical areas to produce pain inhibiting effects, providing a simple and low cost treatment to the clinical routine.Technological advances and non-invasive techniques to modulate brain function have been developed, for instance, Transcranial Direct Current Stimulation (tDCS).

The objective of the present project is to present the tDCS as a new modality of physical rehabilitation for the patient with chronic pain resulting from chikungunya fever. The purpose of the study is to present physical, behavioral and social results of the application of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional status of the individual.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests.

Exclusion Criteria

  • •History of seizures or epileptic disease, pregnancy, states associated with other previously diagnosed rheumatic diseases such as rheumatoid arthritis, gout and lupus, under 18 years and over 65 of age, patients with signs of severity and/or indication for hospitalization.

Arms & Interventions

Active stimulation

Active Comparator

A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex.

Intervention: Transcranial Direct Current Stimulation (Device)

Sham stimulation

Sham Comparator

A constant current (sham) of 2mA will be applied, but the stimulator will be turned off after 30 seconds on the Primary motor cortex.

Intervention: Sham Transcranial Direct Current Stimulation (Device)

Outcomes

Primary Outcomes

Change from baseline Pain at 3 weeks

Time Frame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.

Visual analogue scale.

Change from baseline Pain at 3 weeks

Time Frame: Every day during 3 weeks (before treatment, during treatment and one week after treatment).

Diary of pain

Secondary Outcomes

  • Change from baseline Flexibility at 3 weeks(baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.)
  • Change from baseline Strength at 3 weeks(baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.)
  • Change from baseline Quality of Life at 3 weeks(baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Edson meneses da silva filho

Principal Investigator

Universidade Federal do Rio Grande do Norte

Study Sites (1)

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