Status:
NOT_YET_RECRUITING
Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)
Lead Sponsor:
Hospital da Polícia Militar de Goiás
Collaborating Sponsors:
Hospital das Clínicas de São Paulo - SP
Conditions:
Neuropathic Pain
Sleep Quality
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 throu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06994390
Start Date
March 1 2026
End Date
March 1 2030
Last Update
May 29 2025
Active Locations (1)
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1
Hospital da Polícia Militar de Goiás
Goiânia, Goiás, Brazil, 74423-120