Neuropathic PainNCT06510725
Effect of Multitarget tDCS for Neuropathic Pain
A study testing Multitarget tDCS and Single-target tDCS in people with Neuropathic Pain, run by Xuanwu Hospital, Beijing at 3 sites in China.
Trial summary
This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Multitarget tDCS and Single-target tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 204 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2024to 25 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or males aged between 18 and 75 years.
- Pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at Douleur Neuropathique 4 Questions.
- Pain duration of at least 3 months and average pain intensity scoring ≥4/10 at Numeric Rating Scale.
- Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial.
- Informed consent obtained.
Who cannot join
- Pregnancy or lactation.
- Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy.
- Unable to complete the questionnaire due to language abilities or reduced cognitive functioning.
- Alcohol or substance abuse.
- Common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases.
- Unwilling to comply with the treatment or follow-up assessments.
- Participating in another clinical trial within 3 months prior to enrollment of this clinical trial.
- Any patient deemed unsuitable for enrollment by the investigators.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Second Affiliated Hospital of Tsinghua University
Beijing
Tiantan Hospital
Beijing
Xuanwu Hospital
Beijing
About this study
Official title: Effect of Multitarget Transcranial Direct Current Stimulation (tDCS) in Patients With Neuropathic Pain
This study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.
Read the detailed description
The present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) in patients with neuropathic pain.
The patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. All patients received 20 minutes of active or sham tDCS once a day for 10 consecutive weekdays. In multitarget group, subjects will receive 2mA tDCS applied to M1 and DLPFC alternately, with each target stimulated for 5 sessions. In single-target group, 2mA tDCS will target M1 only. In sham group, subjects will receive sham tDCS. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps.
- Conditions
- Neuropathic Pain
- Being tested
- Multitarget tDCS, Single-target tDCS, Sham tDCS
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multitarget tDCSDevice
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions.
Single-target tDCSDevice
Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays.
Sham tDCSDevice
Subjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays.
| Study group | Role | What they receive |
|---|---|---|
| Multitarget tDCS | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions. Receives: Device: Multitarget tDCS |
| Single-target tDCS | Experimental | Subjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays. Receives: Device: Single-target tDCS |
| Sham tDCS | Sham comparator | Subjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average pain intensity
Change in average pain intensity from baseline to week 2, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory
Measured: from baseline to week 2
Secondary outcomes (14)
Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours
Measured: from baseline to week 6 and week 10
Change in BPI: Maximal pain over the last 24 hours
Measured: from baseline to week 2, week 6 and week 10
Change in BPI: Minimal pain over the last 24 hours
Measured: from baseline to week 2, week 6 and week 10
Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain
Measured: from baseline to week 2, week 6 and week 10
Change in NPSI: Deep pain
Measured: from baseline to week 2, week 6 and week 10
Change in NPSI: Paroxysmal pain
Measured: from baseline to week 2, week 6 and week 10
Change in NPSI: Evoked pain
Measured: from baseline to week 2, week 6 and week 10
Change in NPSI: Paraesthesia
Measured: from baseline to week 2, week 6 and week 10
Change in Hamilton Depression Scale (HAMD)
Measured: from baseline to week 2, week 6 and week 10
Change in Hamilton Anxiety Scale (HAMA)
Measured: from baseline to week 2, week 6 and week 10
Change in Pittsburgh sleep quality index (PSQI)
Measured: from baseline to week 6 and week 10
Change in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L): EQ-VAS
Measured: from baseline to week 2, week 6 and week 10
Change in EQ-5D-5L: Utility score
Measured: from baseline to week 2, week 6 and week 10
Proportion of participants with meaningful improvement compared with baseline (score as 1 or 2) in Patient Global Impression of Change (PGIC)
PGIC includes 7 ranks ranging from 1 to7 (1= very much improved; 2= moderately improved; 3=slightly improved; 4= no change; 5= slightly worsened; 6= moderately worsened; 7= very much worsened)
Measured: Week 2, Week 6, Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Sep 2024
- Primary completion30 Jun 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Second Affiliated Hospital of Tsinghua University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510725
- Sponsor's protocol ID
- zhuhongwei
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Multitarget Transcranial Direct Current Stimulation (tDCS) in Patients With Neuropathic Pain
- ClinicalTrials.gov ID
- NCT06510725
- Acronym / sponsor ID
- zhuhongwei
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- Beijing Tiantan Hospital, Second Affiliated Hospital of Tsinghua University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 19 Jul 2024 (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 study aims to conduct a randomized controlled trial to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) on pain, depression, anxiety, quality of life and sleep, in patients with neuropathic pain.
Detailed description
The present multicenter, randomized, double-blind, sham-controlled, parallel-group trial aims to evaluate the effect of multitarget transcranial direct current stimulation (tDCS) in patients with neuropathic pain.
The patients will be randomized to receive one of 3 treatment arms: multitarget stimulation, single-target stimulation and sham stimulation. All patients received 20 minutes of active or sham tDCS once a day for 10 consecutive weekdays. In multitarget group, subjects will receive 2mA tDCS applied to M1 and DLPFC alternately, with each target stimulated for 5 sessions. In single-target group, 2mA tDCS will target M1 only. In sham group, subjects will receive sham tDCS. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multitarget tDCS | Experimental | Device: Multitarget tDCSSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions. |
| Single-target tDCS | Experimental | Device: Single-target tDCSSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays. |
| Sham tDCS | Sham comparator | Device: Sham tDCSSubjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or males aged between 18 and 75 years.
- Pain fulfilling the criteria for probable or definite neuropathic pain and scoring ≥4/10 at Douleur Neuropathique 4 Questions.
- Pain duration of at least 3 months and average pain intensity scoring ≥4/10 at Numeric Rating Scale.
- Stable pharmacological treatment for at least 4 weeks prior to the study and throughout the trial.
- Informed consent obtained.
Key exclusion criteria (8 listed)
- Pregnancy or lactation.
- Active central nervous system diseases including but not limited to brain tumour, intracranial hypertension, past or current epilepsy.
- Unable to complete the questionnaire due to language abilities or reduced cognitive functioning.
- Alcohol or substance abuse.
- Common contraindications for transcranial direct current stimulation including but not limited to skull defect, implanted device or metal in the brain, severe cardiopulmonary, renal or hepatic diseases.
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 |
|---|---|---|
| Multitarget tDCSSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to DLPFC and M1 alternately for ten consecutive weekdays, with each target stimulated for 5 sessions. | Device | Multitarget tDCS |
| Single-target tDCSSubjects will receive 20 minutes of active transcranial direct current stimulation at 2mA applied to M1 for ten consecutive weekdays. | Device | Single-target tDCS |
| Sham tDCSSubjects will receive 20 minutes of sham transcranial direct current stimulation. Ramps up and down will be applied for 15 seconds each at the beginning and end of the session. The current will be 0 mA during the interval between the initial and final ramps. Subjects will undergo stimulation once a day for ten consecutive weekdays. | Device | Sham tDCS |
Primary outcome
Change in average pain intensity
Time frame: from baseline to week 2
Change in average pain intensity from baseline to week 2, average pain intensity corresponds to average pain over the last 24 hours on the Brief Pain Inventory
14 secondary outcomes
Change in Brief Pain Inventory (BPI): Average pain over the last 24 hours
Time frame: from baseline to week 6 and week 10
Change in BPI: Maximal pain over the last 24 hours
Time frame: from baseline to week 2, week 6 and week 10
Change in BPI: Minimal pain over the last 24 hours
Time frame: from baseline to week 2, week 6 and week 10
Change in Neuropathic Pain Symptoms Inventory (NPSI): Burning pain
Time frame: from baseline to week 2, week 6 and week 10
Change in NPSI: Deep pain
Time frame: from baseline to week 2, week 6 and week 10
Change in NPSI: Paroxysmal pain
Time frame: from baseline to week 2, week 6 and week 10
Change in NPSI: Evoked pain
Time frame: from baseline to week 2, week 6 and week 10
Change in NPSI: Paraesthesia
Time frame: from baseline to week 2, week 6 and week 10
Change in Hamilton Depression Scale (HAMD)
Time frame: from baseline to week 2, week 6 and week 10
Change in Hamilton Anxiety Scale (HAMA)
Time frame: from baseline to week 2, week 6 and week 10
Change in Pittsburgh sleep quality index (PSQI)
Time frame: from baseline to week 6 and week 10
Change in five-level EuroQol five-dimensional questionnaire (EQ-5D-5L): EQ-VAS
Time frame: from baseline to week 2, week 6 and week 10
Change in EQ-5D-5L: Utility score
Time frame: from baseline to week 2, week 6 and week 10
Proportion of participants with meaningful improvement compared with baseline (score as 1 or 2) in Patient Global Impression of Change (PGIC)
Time frame: Week 2, Week 6, Week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multitarget tDCS and Single-target tDCS in people with Neuropathic Pain, run by Xuanwu Hospital, Beijing at 3 sites in China.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain intensity (time frame: from baseline to week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.