ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02993952
Previous Study | Return to List | Next Study

tDCS and Its Therapeutic Effects in CK Fever

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02993952
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Edson meneses da silva filho, Universidade Federal do Rio Grande do Norte

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.


Condition or disease Intervention/treatment Phase
Chikungunya Fever Device: Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever
Actual Study Start Date : December 12, 2016
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : March 10, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya Fever

Arm Intervention/treatment
Active Comparator: Active stimulation
A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex.
Device: Transcranial Direct Current Stimulation
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.

Sham Comparator: Sham stimulation
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
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.




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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. ]
    Diagnosing Neuropathic Pain - DN4 Questionnaire

  4. 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. ]
    McGill Pain Questionnaire short brazilian version (Br- MPQ)

  5. 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. ]
    Brief Pain Inventory (Short Form).


Secondary Outcome Measures :
  1. Change from baseline Quality of Life 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. ]
    Short Form 36 Health Survey (SF-36).

  2. Change from baseline Flexibility 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. ]
    Sit and Reach Flexibility Test.

  3. Change from baseline Flexibility 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. ]
    Back Scratch Test.

  4. Change from baseline Strength 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. ]
    The 30-Second Chair Stand Test.

  5. Change from baseline Strength 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. ]
    Elbow flexion strength test

  6. Change from baseline Strength 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. ]
    Manual Muscle Testing (Hand Dynamometer)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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): NCT02993952


Locations
Brazil
Federal University of Rio Grande do Norte
Santa cruz, Rio Grande do Norte, Brazil, 59200-000
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
Investigators
Study Director: Rodrigo Pegado Freitas, PhD Universidade Federal do Rio Grande do Norte
Principal Investigator: Edson Meneses Filho, Graduate Universidade Federal do Rio Grande do Norte

Responsible Party: Edson meneses da silva filho, Principal Investigator, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT02993952     History of Changes
Other Study ID Numbers: 1.839.742
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fever
Chikungunya Fever
Body Temperature Changes
Signs and Symptoms
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases