Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)
- Sponsor
- Hospital da Polícia Militar de Goiás
- Study ID
- NCT06994390
- Status
- Not Yet Recruiting
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Conditions
- Neuropathic Pain
- Sleep Quality
- Transcranial Direct Current Stimulation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- First listed
- May 29, 2025
- Start date
- Mar 1, 2026
- Status verified
- May 2025
- Primary completion
- Mar 1, 2029
- Completion
- Mar 1, 2030
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Anodal tdcs over the primary motor (M1)Anode placement will be positioned over M1, using the international 10-20 EEG system (C3/C4 for left or right M1). Cathode placement will be on the contralateral supraorbital area (above the eyebrow) to complete the circuit.
- Active Comparator: Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC)Anode placement positioned over dorsolateral prefrontal cortex (DLPFC), using the international 10-20 EEG system (F3/F4 for left or right DLPFC). Cathode placement will be on the contralateral supraorbital area (above the eyebrow) to complete the circuit.
- Sham Comparator: sham tdcs over M1 or DLPFCThe sham group will be divided in half of participants with Sham M1 and the other half as Sham DLPFC.
Primary Outcome Measure
pain intensity by VAS [ Time Frame: at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention. ]
Central Contacts
- Eline RF Barbosa, MD, MD+5562981787456
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