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 — DEVICE
    This 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 — DEVICE
    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.

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 DLPFC
    The 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

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