Chikungunya FeverNCT02993952
tDCS and Its Therapeutic Effects in CK Fever
A study testing Transcranial Direct Current Stimulation in people with Chikungunya Fever, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chikungunya Fever
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Dec 2016to 10 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Norte
Santa Cruz, Rio Grande do Norte, 59200-000
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever
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
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Medical subject headings
- Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | A constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex. Receives: 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. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Pain at 3 weeks
Diary of pain
Measured: Every day during 3 weeks (before treatment, during treatment and one week after treatment).
Change from baseline Pain at 3 weeks
Visual analogue scale.
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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
Short Form 36 Health Survey (SF-36).
Measured: 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
Sit and Reach Flexibility Test.
Measured: 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
Back Scratch Test.
Measured: 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
The 30-Second Chair Stand Test.
Measured: 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
Elbow flexion strength test
Measured: 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
Manual Muscle Testing (Hand Dynamometer)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start12 Dec 2016
- Primary completion20 Feb 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chikungunya FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edson meneses da silva filho, Universidade Federal do Rio Grande do Norte
- Investigators
- Rodrigo Pegado Freitas, PhD, Study director, Universidade Federal do Rio Grande do NorteEdson Meneses Filho, Graduate, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993952
- Sponsor's protocol ID
- 1.839.742
- Status last verified
- Apr 2017
- First submitted
- 5 Dec 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever
- ClinicalTrials.gov ID
- NCT02993952
- Acronym / sponsor ID
- 1.839.742
- Conditions
- Chikungunya Fever
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 15 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Transcranial Direct Current StimulationA constant current (anodic) of 2mA will be applied for 20 minutes on the Primary motor cortex. |
| Sham stimulation | Sham comparator | Device: Sham Transcranial Direct Current StimulationA constant current (sham) of 2mA will be applied, but the stimulator will be turned off after 30 seconds on the Primary motor cortex. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationFor 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. | Device | Active stimulation |
| Sham Transcranial Direct Current StimulationFor 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. | Device | Sham stimulation |
Primary outcome
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
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: 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
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)
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).
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Pegado Freitas, PhD study director
Universidade Federal do Rio Grande do Norte
Edson Meneses Filho, Graduate principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Chikungunya Fever, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Pain at 3 weeks (time frame: Every day during 3 weeks (before treatment, during treatment and one week after treatment).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.