Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital da Polícia Militar de Goiás
About this trial
This project protocol investigates the efficacy of transcranial direct current stimulation (tDCS) in treating neuropathic pain and improving sleep quality among Brazilian military personnel. Given the high prevalence of chronic pain and sleep disturbances in this population, and the limitations of current pharmacological treatments, our randomized, triple-blinded, sham-controlled trial explores the potential of tDCS as a non-invasive therapeutic intervention. The results of this study could have a significant impact on improving the well-being and performance of military personnel, while also reducing healthcare costs associated with long-term medication use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Military personnel (active and veterans) with chronic pain due to central or peripheral neuropathy and poor sleep quality;
Age over 18 years old;
Defined chronic NeP according to current guidelines (ICD-10 codes OR DN-4);
Pain with an average intensity score above 40/100 mm on a visual analogue scale (VAS);
Disqualifiers
General contraindications for tDCS: past head trauma, current epilepsy, intracranial ferromagnetic components, pacemaker, implanted microprocessors (i.e., cochlear implants);
Pregnancy;
Known major psychiatric disorders (as assessed by the DSM-5, e.g., psychosis), history of substance abuse, or work litigation issues;
History of chronic refractory migraines;
Trial design
Design model
Parallel
Treatments tested in this trial
tDCS
DeviceThis group will receive single-phase direct current with an intensity of 2 mA up. Electrodes with a size of 35cm² (5 x 7 centimeters) will be used. Electrodes will be placed on the scalp, fixed with elastic bands, and immersed in 10 to 12 mL of saline solution.
sham intervention
DeviceThe device displays will be identical across active and sham groups, and to ensure blinding, an active current will be applied for 30 seconds at the beginning and end of the sham stimulation to mimic the sensation of the current ramp experienced in active stimulation. Stimulations of less than 3 minutes of tDCS do not induce cortical excitability effects, according to Nitsche and Paulus (2000), being safely inactive for the expected results.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Anodal tdcs over the primary motor (M1)Active comparator 1 intervention
Group B: Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC)Active comparator 1 intervention
Group C: sham tdcs over M1 or DLPFCSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
pain intensity by VAS
The primary outcome is a reduction in pain intensity by at least 30% (Dworkim et al., 2004; Farrar et al 2001). It will be assessed using the 100 mm Visual Analogue Scale (VAS), which consists of straight lines 100 mm long indicating "no pain" on one end and "worst possible pain or most intense pain possible" on the other (Huskisson, 1974). The VAS is scored by measuring the distance from the "no pain" end of the line. Pain intensity will be assessed daily during the 10day intervention.
Time frame
at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.Secondary outcomes
1
Pittsburgh Sleep Quality Index (PSQI)
Before and after the interventions, sleep secondary outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which global score ranges from 0 to 21, with a higher score indicating poorer sleep quality. Each of the 7 component scores also range from 0 to 3, where a higher score on each component signifies more difficulty.
Time frame
It will be measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.2
Epworth Sleepiness Scale (ESS)
Before and after the interventions, the Epworth Sleepiness Scale (ESS) will be applied. The ESS has a minimum score of 0 and a maximum score of 24. Higher scores indicate greater daytime sleepiness, with scores above 10 suggesting excessive daytime sleepiness. A higher score is therefore indicative of a worse outcome, as it signifies a greater tendency to fall asleep in various situations.
Time frame
at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.3
the Visual Analogue Scale for Fatigue Severity (VAS-F)
Before and after the interventions, we will apply the Visual Analogue Scale for Fatigue Severity (VAS-F). The VAS-F uses a 100 mm line and scores are determined by measuring the distance from one end of the line to the point the individual marks, resulting in a score between 0 and 100. A higher score indicates greater fatigue severity.
Time frame
measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.4
Polysomnographic evaluation - time
Sleep evaluation with Type 2 polysomnography (PSG) will be recorded at baseline and will access time in bed (minutes), time to sleep onset (minutes), total sleep time (minutes), sleep latency (minutes), REM latency (minutes), wake after sleep onset (minutes).
Time frame
PSG will be measured at baseline and at the end of the ten-day treatment.Other outcomes
1
Pittsburgh Sleep Quality Index Addendum for Posttraumatic Stress Disorder (PSQI-A)
A possible confounder to be controlled for will be assessed by the Pittsburgh Sleep Quality Index Addendum for Posttraumatic Stress Disorder (PSQI-A) addresses patients exposed to trauma and was validated in U.S. male military veterans (Insana et al., 2013) and also in Portuguese by Gonçalves and Lima (2014). Seven items assess the frequency of hot flashes; general nervousness; memories or nightmares of the traumatic experience; severe anxiety or panic, not related to traumatic memories; nightmares, not related to traumatic memories; episodes of terror or screaming during sleep without full awakening; and episodes of staged dreams (Germain et al., 2005). The PSQI-A (Pittsburgh Sleep Quality Index Addendum for Posttraumatic Stress Disorder) ranges from 0 to 21. Higher scores indicate a poorer outcome in PTSD symptom severity and a worse sleep quality. Scores of 5 or less generally indicate good sleep quality. Higher scores on the PSQI-A are also associated with more combat exposure.
Time frame
at baseline and at the end of 10-day treatment2
the Depression-Anxiety-Stress Scales-21 (DASS-21)
Possible confounders to be controlled for will be assessed by the Depression-Anxiety-Stress Scales-21 (DASS-21) validated for Portuguese (Lovibond and Lovibond, 1995; Vignola and Tucci, 2014), that measures the levels of depression, anxiety and stress based on behaviors and feelings experienced in the last seven days. The DASS-21 has a score range from 0 to 63, in which the total score is calculated by summing the scores from all three subscales (depression, anxiety and stress). Higher scores indicate a more severe or frequent experience of depression, anxiety, and stress symptoms, i.e., a worse outcome.
Time frame
at baseline and at the end of 10-day treatment3
Sociodemografic characteristics - DOB
The sociodemographic data collected will include date of birth (DD/MM/YYYY)
Time frame
at baseline4
Sociodemografic characteristics - age
The sociodemographic data collected will include age (years)
Time frame
at baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital da Polícia Militar de Goiás
Lead sponsor
Hospital das Clínicas de São Paulo - SP
Collaborator
Source ClinicalTrials.gov
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