Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)
120 patients around the world
Available in Brazil
The intervention will be carried out into two-weeks daily consecutive sessions of 20
minutes each, with 1 session per day, and a weekend interval. Direct current stimulation
will be administered through an electrical stimulator model MicroEstim Genius (NKL),
Brusque, Brazil. During the session, the participants will be awake and seated in a
comfortable seat. The environment will be air-conditioned, free of visual and auditory
stimuli.
The sessions will be conducted by a trained health professional. The groups will receive
single-phase direct current with an intensity of 2 mA up, according to data presented by
Pacheco-Barrios et al. (2021). 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.
The electrode montage will be performed for one of two possible targets: anodal
stimulation over DLPFC or anodal stimulation over M1, and also sham in both targets
according to the participants' designations after randomization to one of the three
groups.
The 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.
Hospital da Polícia Militar de Goiás
1Research sites
120Patients around the world
This study is for people with
Neuropathic Pain
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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).
Medication stability (chronic pain, depression, anxiety, sleep) for at least six weeks.
Patients with bad sleep quality identified by the Pittsburgh Sleep Quality Index (PSQI) of 5 or more who do not improve under conventional treatment.
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.
Non-treated moderate to severe sleep apnea defined as apnea/hypopnea index greater than 15 events per hour in baseline polysomnography.
Skin conditions such as psoriasis or eczema that involve the scalp (Thair et al, 2017).
Cancer-related pain.
BMI >35, due to increased reports of pain associated with increased BMI (Basem, et al., 2021; Stokes et al., 2020).
Patients who do not sign informed consent or do not want to participate in the study.
Sites
Hospital da Polícia Militar de Goiás
Av. Eng. Atílio Corrêa Lima, 1549 - Cidade Jardim, Goiânia - GO, 74425-030, Brazil