Neuropathic PainNeuBRAINNCT06994390
Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel (NeuBRAIN Trial)
A study testing tDCS in people with Neuropathic Pain and Sleep Quality, run by Hospital da Polícia Militar de Goiás at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Sleep Quality, Transcranial Direct Current Stimulation
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2026to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital da Polícia Militar de Goiás
Goiânia, Goiás, 74423-120
Eline RF Barbosa, MD, +55623235-6223, hpm@hpm.org.br
About this study
Official title: Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel Randomized Controlled Trial
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.
Read 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 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.
- Being tested
- tDCS, sham intervention
- Keywords
- transcranial current stimulation, neuropathic pain, sleep
- Medical subject headings
- Neuralgia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called transcranial direct current stimulation
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 interventionDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Before and after the interventions, sleep secondary outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI), which global score ranges from 0 to 21, with a higher score indicating poorer sleep quality. Each of the 7 component scores also range from 0 to 3, where a higher score on each component signifies more difficulty.
Measured: 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)
Before and after the interventions, the Epworth Sleepiness Scale (ESS) will be applied. The ESS has a minimum score of 0 and a maximum score of 24. Higher scores indicate greater daytime sleepiness, with scores above 10 suggesting excessive daytime sleepiness. A higher score is therefore indicative of a worse outcome, as it signifies a greater tendency to fall asleep in various situations.
Measured: 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)
Before and after the interventions, we will apply the Visual Analogue Scale for Fatigue Severity (VAS-F). The VAS-F uses a 100 mm line and scores are determined by measuring the distance from one end of the line to the point the individual marks, resulting in a score between 0 and 100. A higher score indicates greater fatigue severity.
Measured: measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.
Polysomnographic evaluation - time
Sleep evaluation with Type 2 polysomnography (PSG) will be recorded at baseline and will access time in bed (minutes), time to sleep onset (minutes), total sleep time (minutes), sleep latency (minutes), REM latency (minutes), wake after sleep onset (minutes).
Measured: PSG will be measured at baseline and at the end of the ten-day treatment.
Polysomnographic evaluation - arousal index
The Arousal Index (AI) in polysomnography will be measured by counting the total number of arousals during sleep and dividing it by the total sleep time.
Measured: PSG will be measured at baseline and at the end of the ten-day treatment.
Polysomnographic evaluation - sleep efficiency
Sleep efficiency (SE) will be calculated as the total sleep time (TST) divided by the total time in bed, multiplied by 100. A higher SE percentage indicates that more time in bed is spent actually sleeping. Normal sleep efficiency is generally considered to be 85% or higher.
Measured: PSG will be measured at baseline, at the end of the ten-day treatment.
Polysomnographic evaluation- sleep stages
Sleep stages will be scored by analyzing 30-second epochs of polysomnographic recordings using electroencephalogram (EEG), electrooculogram (EOG), and electromyogram (EMG) signals.
Measured: at baseline, at the end of the ten-day treatment.
Polysomnographic evaluation- PLMI
The Periodic Limb Movement Index (PLMI) is calculated as the number of periodic limb movements during sleep (PLMS) per hour of sleep time. According to the American Academy of Sleep Medicine (AASM) scoring criteria, a limb movement (LM) is scored if there is an increase in anterior tibialis electromyogram (EMG) activity of more than 8 microvolts above resting EMG, lasting between 0.5 to 10 seconds. Periodic limb movements (PLMS) are defined as a series of at least four consecutive limb movements, each separated by an inter-movement interval of 5 to 90 seconds. The PLMI is computed by dividing the total number of PLMS by the total sleep time in hours, yielding PLMS per hour of sleep (PLMS/h). A PLMI greater than 15 per hour in adults is considered clinically significant for periodic limb movement disorder.
Measured: PSG will be measured at baseline, at the end of the ten-day treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital da Polícia Militar de Goiás
- Sponsor type
- Research network
- Collaborators
- University of Sao Paulo General Hospital
- Responsible party
- Principal investigator, Eline Rozária Ferreira Barbosa, Hospital da Polícia Militar de Goiás
- Investigators
- Clarissa Bueno, MD, PhD, Study director, São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994390
- Sponsor's protocol ID
- NeuBRAIN RCT protocol
- Acronym
- NeuBRAIN
- Status last verified
- May 2025
- First submitted
- 7 Apr 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data will be available, after de-identification. There will be shared the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code.
Publications
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.
PubMed 16564618Nitsche 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.
PubMed 10990547Mehta 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.
PubMed 26193817Pacheco-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.
PubMed 32845195Farrar 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.
PubMed 11690728
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Pain Intervention With tDCS in Brazilian Military Personnel Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06994390
- Acronym / sponsor ID
- NeuBRAIN / NeuBRAIN RCT protocol
- Keywords
- transcranial current stimulation, neuropathic pain, sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital da Polícia Militar de GoiásResearch network
- Collaborators
- University of Sao Paulo General Hospital
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Anodal tdcs over the primary motor (M1) | Active comparator | Device: tDCSAnode 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. |
| Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC) | Active comparator | Device: tDCSAnode 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 tdcs over M1 or DLPFC | Sham comparator | Device: sham interventionThe sham group will be divided in half of participants with Sham M1 and the other half as Sham DLPFC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: transcranial direct current stimulationThis 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. | Device | Anodal tdcs over the dorsolateral prefrontal cortex (DLPFC), Anodal tdcs over the primary motor (M1) |
| sham interventionThe 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. | Device | sham tdcs over M1 or DLPFC |
Primary outcome
pain intensity by VAS
Time frame: at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.
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.
8 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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)
Time frame: 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)
Time frame: measured at baseline, at the end of the ten-day treatment and at follow-up, three weeks post-intervention.
Polysomnographic evaluation - time
Time frame: PSG will be measured at baseline and at the end of the ten-day treatment.
Polysomnographic evaluation - arousal index
Time frame: PSG will be measured at baseline and at the end of the ten-day treatment.
Polysomnographic evaluation - sleep efficiency
Time frame: PSG will be measured at baseline, at the end of the ten-day treatment.
Polysomnographic evaluation- sleep stages
Time frame: at baseline, at the end of the ten-day treatment.
Polysomnographic evaluation- PLMI
Time frame: PSG will be measured at baseline, at the end of the ten-day treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Background: PubMed 16564618Fregni 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.
- Background: PubMed 10990547Nitsche 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.
- Background: PubMed 26193817Mehta 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.
- Background: PubMed 32845195Pacheco-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.
- Background: PubMed 11690728Farrar 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.
- Individual participant dataSharing planned: Yes. All individual participant data will be available, after de-identification. There will be shared the study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clarissa Bueno, MD, PhD study director
São Paulo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Neuropathic Pain and Sleep Quality, run by Hospital da Polícia Militar de Goiás at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eline RF Barbosa, MD, MD (+5562981787456, elinebarbosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06994390, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.