tDCS and Its Therapeutic Effects in CK Fever

Chikungunya Fever Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993952
• Other study ID #: 1.839.742
• Status: Completed
• Phase: N/A
• First received: December 5, 2016
• Last updated: April 17, 2017
• Start date: December 12, 2016
• Est. completion date: March 10, 2017

Study information

• Verified date: April 2017
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chikungunya Fever
• Fever

Intervention

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 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Norte	Santa cruz	Rio Grande do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline Pain at 3 weeks	Diary of pain	Every day during 3 weeks (before treatment, during treatment and one week after treatment).
Primary	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.
Primary	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.
Primary	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.
Primary	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	Change from baseline Quality of Life at 3 weeks	Short Form 36 Health Survey (SF-36).	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	Change from baseline Flexibility at 3 weeks	Sit and Reach Flexibility Test.	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	Change from baseline Flexibility at 3 weeks	Back Scratch Test.	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	Change from baseline Strength at 3 weeks	The 30-Second Chair Stand Test.	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	Change from baseline Strength at 3 weeks	Elbow flexion strength test	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	Change from baseline Strength at 3 weeks	Manual Muscle Testing (Hand Dynamometer)	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.