Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)

NCT06994390 | Not Yet Recruiting DMC

• 1 other identifier: NeuBRAIN RCT protocol
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neuropathic Pain; Sleep Quality; Transcranial Direct Current Stimulation

Keywords

transcranial current stimulation; neuropathic pain; sleep

Outcome Measures

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.

  at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.

Secondary Outcomes (8)

• Pittsburgh Sleep Quality Index (PSQI)

  It will be measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.

• Epworth Sleepiness Scale (ESS)

  at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.

• the Visual Analogue Scale for Fatigue Severity (VAS-F)

  measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.

• Polysomnographic evaluation - time

  PSG will be measured at baseline and at the end of the ten-day treatment.

• Polysomnographic evaluation - arousal index

  PSG will be measured at baseline and at the end of the ten-day treatment.

Other Outcomes (10)

• Pittsburgh Sleep Quality Index Addendum for Posttraumatic Stress Disorder (PSQI-A)

  at baseline and at the end of 10-day treatment

• the Depression-Anxiety-Stress Scales-21 (DASS-21)

  at baseline and at the end of 10-day treatment

• Sociodemografic characteristics - DOB

  at baseline

Study Arms (3)

Anodal tdcs over the primary motor (M1)

ACTIVE COMPARATOR

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.

Device: tDCS

Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC)

ACTIVE COMPARATOR

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.

Device: tDCS

sham tdcs over M1 or DLPFC

SHAM COMPARATOR

The sham group will be divided in half of participants with Sham M1 and the other half as Sham DLPFC.

Device: sham intervention

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.

Also known as: transcranial direct current stimulation

Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC); Anodal tdcs over the primary motor (M1)

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.

sham tdcs over M1 or DLPFC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital da Polícia Militar de Goiás: lead
• Hospital das Clínicas de São Paulo - SP: collaborator

Study Sites (1)

Hospital da Polícia Militar de Goiás

Goiânia, Goiás, 74423-120, Brazil

Location

Related Publications (5)

• Fregni F, Boggio PS, Lima MC, Ferreira MJ, Wagner T, Rigonatti SP, Castro AW, Souza DR, Riberto M, Freedman SD, Nitsche MA, Pascual-Leone A. A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury. Pain. 2006 May;122(1-2):197-209. doi: 10.1016/j.pain.2006.02.023. Epub 2006 Mar 27.

  PMID: 16564618 BACKGROUND

• Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

  PMID: 10990547 BACKGROUND

• Mehta S, McIntyre A, Guy S, Teasell RW, Loh E. Effectiveness of transcranial direct current stimulation for the management of neuropathic pain after spinal cord injury: a meta-analysis. Spinal Cord. 2015 Nov;53(11):780-5. doi: 10.1038/sc.2015.118. Epub 2015 Jul 21.

  PMID: 26193817 BACKGROUND

• Pacheco-Barrios K, Cardenas-Rojas A, Thibaut A, Costa B, Ferreira I, Caumo W, Fregni F. Methods and strategies of tDCS for the treatment of pain: current status and future directions. Expert Rev Med Devices. 2020 Sep;17(9):879-898. doi: 10.1080/17434440.2020.1816168. Epub 2020 Sep 15.

  PMID: 32845195 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Sleep Initiation and Maintenance Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Clarissa Bueno, MD, PhD

  São Paulo University

  STUDY DIRECTOR

Central Study Contacts

Eline RF Barbosa, MD, MD

CONTACT

+5562981787456; elinebarbosa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A triple-blinding strategy will be implemented, including participants and outcome assessors, as well as staff responsible for recruitment and statistical analysis. To ensure proper intervention, only the health professional administering the treatment will know each participant's assigned group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention will be carried out into two-weeks daily consecutive sessions of 20 minutes each, with 1 session/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.

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after one year of the publication of the main results (2030 March) - for 3 years.
• Access Criteria: Data will be shared with researchers upon request for analyses related to the study's objectives, via a secure data repository.

Locations

BR (1)