tDCS and Its Therapeutic Effects in CK Fever

NCT02993952 | Completed

• 1 other identifier: 1.839.742
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chikungunya Fever

Outcome Measures

Primary Outcomes (5)

• Change from baseline Pain at 3 weeks

  Diary of pain

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

• Change from baseline Pain at 3 weeks

  Visual analogue scale.

  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 Pain at 3 weeks

  Diagnosing Neuropathic Pain - DN4 Questionnaire

  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 Pain at 3 weeks

  McGill Pain Questionnaire short brazilian version (Br- MPQ)

  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 Pain at 3 weeks

  Brief Pain Inventory (Short Form).

  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.

Secondary Outcomes (6)

• 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.

• 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 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 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.

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

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

Device: Transcranial Direct Current Stimulation

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.

Device: Sham Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.

Active stimulation

Sham Transcranial Direct Current Stimulation DEVICE

For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator was turned off after 30 seconds of stimulation. Therefore, patients in the sham group felt the initial itching sensation but received no current for the rest of the stimulation period.

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (1)

Federal University of Rio Grande do Norte

Santa Cruz, Rio Grande do Norte, 59200-000, Brazil

Location

MeSH Terms

Conditions

Chikungunya Fever

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rodrigo Pegado Freitas, PhD

  Universidade Federal do Rio Grande do Norte

  STUDY DIRECTOR

• Edson Meneses Filho, Graduate

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 15, 2016
• Study Start: December 12, 2016
• Primary Completion: February 20, 2017
• Study Completion: March 10, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)