Ignite Creation Date:
2024-05-06 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05321693
Status:
UNKNOWN
Last Update Posted:
2022-04-11
First Post:
2022-03-25
Brief Title:
Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia
Sponsor:
Centro Universitario La Salle
Organization:
Centro Universitario La Salle
Study Overview
Official Title:
Neuromodulatory Effects of Transcranial Pulsed Current Stimulation in Fibromyalgia a Randomized Clinical Trial Double-blinded Controlled With Sham
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia FM is a functional syndrome characterized by musculoskeletal diffuse and persistent 3 months chronic pain that is also characterized by sleep disturbances fatigue humor changes and cognitive and psychological changes Transcranial Pulsed Current Stimulation tPCS is a new Transcranial Electrical Stimulation tES that has been studied as a treatment option for chronic pain and neurological conditions Studies have shown that tPCS is capable of pain and cognitive modulation however there are not enough studies with evidenceofits efficacyTherefore the primary aim of this study is to evaluate the effects of tPCS in pain evaluated through Visual Analogue Scale VAS in FM patients besides that it is aimed to evaluate the effects of tPCS on quality of life cognitive impairments pain pressure threshold descending inhibitory system of pain and serum levels of Brain Derived Neurotrophic Factor BDNF and S100 Calcium-Binding Protein B S100B A randomized double-blinded controlled with sham clinical trial will be conducted with 70 Critical f 2003 ES 076 alpha 005 power 080 women with Fibromyalgia from 30 to 65 years with pain on the Visual Analogue Scale VAS higher than 6 in the last 3 months All patients will read and sign an Informed Consent Form ICF Each patient will be randomized to either 14 sessions of tPCS 2mA 6-10Hz 1-20ms 20-25 minutes or Sham Patients will complete the following questionnairestests Visual Analogue Scale VAS Pittsburgh Sleep Quality Index PSQI Fibromyalgia Impact Questionnaire FIQ Pain Catastrophizing Scale PCS Profile of Chronic Pain PCP Conditioned Pain Modulation Task CPM-T Pain Pressure Threshold Task PPT-T ReyAuditory-Verbal Learning Test RAVLT Controlled Oral Word Association Test COWAT and blood collection for serum levels of BDNF and S100B For the main outcome comparison between variables during time will be made through linear regression with an adjustment for baseline levels and possible confounders
Detailed Description:
Recruitment The study will be held in a clinical center at Novo Hamburgo RS -BrazilData collection will begin in December 2021 and it will end when sample size is achieved A targeted approach will be used recruiting referrals from clinics in the region of the study setting along with patients from the clinical center where the trial will be conducted Besides that posters will be placed in common areas and posted on social media Inclusion Criteria women from 30 to 65 years old FM diagnosis according to ACR criteria 2016 pain on VAS equal to or higher than 6 in the last 3 months chronic stable treatment over the past 3 months
Exclusion Criteria pregnancy or lack of contraceptive use history of alcohol or drug abuse in the last 6 months neurological disorders cardiac arrhythmia use of drugs that change vascular response history of head trauma mild or severe neurosurgery decompensated systemic diseases current diagnosis or history of cancer
tPCSThe procedure will begin with placement of bilateral circular electrodes in the inferior ear lobe ECG position A1 fixed by an ear clip The electrodes radius will be approximately 0785cm2 Current has a peak pulse amplitude of 2mA with a frequency range from 6 to 10 Hz A battery-powered current stimulator will be used This device provides stimulation through biphasic and alternating square wave pulse with random pulse width range from 1 to 20 ms tPCS sessions will last 20 minutes plus 5 minutes for setting up meanwhile when questionnaires and tests are applied sessions can last 1 to 2 hours Sessions will be made in a 14 way in which outcomes will be evaluated before and after the first session and after the last session Studies display evidence of clinical improvement after 5 sessions of transcranial electrical stimulation in FM A standardized questionnaire will be performed in order to observe adverse effects immediately after the interventionSham tPCSThe current will only be applied for the first 30 seconds Patients may notice the same sensation of initial stimulation but will not receive the current for the remaining time Analogue to tPCS 5 sessions will be performed
Exclusion Criteria pregnancy or lack of contraceptive use history of alcohol or drug abuse in the last 6 months neurological disorders cardiac arrhythmia use of drugs that change vascular response history of head trauma mild or severe neurosurgery decompensated systemic diseases current diagnosis or history of cancer
tPCSThe procedure will begin with placement of bilateral circular electrodes in the inferior ear lobe ECG position A1 fixed by an ear clip The electrodes radius will be approximately 0785cm2 Current has a peak pulse amplitude of 2mA with a frequency range from 6 to 10 Hz A battery-powered current stimulator will be used This device provides stimulation through biphasic and alternating square wave pulse with random pulse width range from 1 to 20 ms tPCS sessions will last 20 minutes plus 5 minutes for setting up meanwhile when questionnaires and tests are applied sessions can last 1 to 2 hours Sessions will be made in a 14 way in which outcomes will be evaluated before and after the first session and after the last session Studies display evidence of clinical improvement after 5 sessions of transcranial electrical stimulation in FM A standardized questionnaire will be performed in order to observe adverse effects immediately after the interventionSham tPCSThe current will only be applied for the first 30 seconds Patients may notice the same sensation of initial stimulation but will not receive the current for the remaining time Analogue to tPCS 5 sessions will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None