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tDCS and Its Therapeutic Effects in CK Fever

Primary Purpose

Chikungunya Fever

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sham Transcranial Direct Current Stimulation
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chikungunya Fever

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Federal University of Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active stimulation

Sham stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline Pain at 3 weeks
Diary of pain
Change from baseline Pain at 3 weeks
Visual analogue scale.
Change from baseline Pain at 3 weeks
Diagnosing Neuropathic Pain - DN4 Questionnaire
Change from baseline Pain at 3 weeks
McGill Pain Questionnaire short brazilian version (Br- MPQ)
Change from baseline Pain at 3 weeks
Brief Pain Inventory (Short Form).

Secondary Outcome Measures

Change from baseline Quality of Life at 3 weeks
Short Form 36 Health Survey (SF-36).
Change from baseline Flexibility at 3 weeks
Sit and Reach Flexibility Test.
Change from baseline Flexibility at 3 weeks
Back Scratch Test.
Change from baseline Strength at 3 weeks
The 30-Second Chair Stand Test.
Change from baseline Strength at 3 weeks
Elbow flexion strength test
Change from baseline Strength at 3 weeks
Manual Muscle Testing (Hand Dynamometer)

Full Information

First Posted
December 5, 2016
Last Updated
April 17, 2017
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT02993952
Brief Title
tDCS and Its Therapeutic Effects in CK Fever
Official Title
Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
March 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chikungunya Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation
Arm Type
Active Comparator
Arm Description
A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Direct Current Stimulation
Intervention Description
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 Measure Information:
Title
Change from baseline Pain at 3 weeks
Description
Diary of pain
Time Frame
Every day during 3 weeks (before treatment, during treatment and one week after treatment).
Title
Change from baseline Pain at 3 weeks
Description
Visual analogue scale.
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.
Title
Change from baseline Pain at 3 weeks
Description
Diagnosing Neuropathic Pain - DN4 Questionnaire
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.
Title
Change from baseline Pain at 3 weeks
Description
McGill Pain Questionnaire short brazilian version (Br- MPQ)
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.
Title
Change from baseline Pain at 3 weeks
Description
Brief Pain Inventory (Short Form).
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.
Secondary Outcome Measure Information:
Title
Change from baseline Quality of Life at 3 weeks
Description
Short Form 36 Health Survey (SF-36).
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.
Title
Change from baseline Flexibility at 3 weeks
Description
Sit and Reach Flexibility Test.
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.
Title
Change from baseline Flexibility at 3 weeks
Description
Back Scratch Test.
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.
Title
Change from baseline Strength at 3 weeks
Description
The 30-Second Chair Stand Test.
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.
Title
Change from baseline Strength at 3 weeks
Description
Elbow flexion strength test
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.
Title
Change from baseline Strength at 3 weeks
Description
Manual Muscle Testing (Hand Dynamometer)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Pegado Freitas, PhD
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Edson Meneses Filho, Graduate
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio Grande do Norte
City
Santa cruz
State/Province
Rio Grande do Norte
ZIP/Postal Code
59200-000
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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tDCS and Its Therapeutic Effects in CK Fever

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