Neuropathic Pain, Nociceptive PainAiTBSNCT07148388
Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain
A study testing Repetitive transcranial magnetic stimulation in people with Neuropathic Pain, Nociceptive Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The present study was designed to be the first to evaluate the efficacy of the AiTBS protocol to relieve neuropathic pain in a therapeutic setting, i.e. with repeated stimulation sessions. The investigator directly compared the analgesic efficacy of AiTBS versus conventional 10-Hz rTMS delivered to the left M1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain, Nociceptive Pain
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2025to 31 Dec 2027
- 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
- IASP diagnosis of peripheral neuropathic pain;
- At least three months after the onset of pain;
- At least moderate pain intensity (≥ 3 assessed by VAS or NRS);
- 18 years or older;
- Stable medical treatment from 2 weeks before allocation to the end of the trial;
- Willing to receive TMS treatment and capable of fulfilling clinical assessments.
Who cannot join
- Contradictions to TMS treatment, such as metal implants or seizure;
- Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);
- Aphasia or cognitive disorders (Mini mental state examination ≤ 24);
- Severe clinical disorders caused by tumor or other conditions;
- Severe cardiopulmonary dysfunction or extreme weakness;
- History of substance abuse (alcohol, drugs).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Ying Liu, 15595512306, 350373328@qq.com
About this study
Official title: Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain
The present study was designed to be the first to evaluate the efficacy of the AiTBS protocol to relieve neuropathic pain in a therapeutic setting, i.e. with repeated stimulation sessions. The investigator directly compared the analgesic efficacy of AiTBS versus conventional 10-Hz rTMS delivered to the left M1. In addition to pain experiences, The investigator examined the effects of intervention on corticospinal excitability that assessed by TMS-EEG. The working hypothesis was that AiTBS would result in larger analgesic and significant cortical excitability changes compared to 10-Hz rTMS.
Eligible patients were randomly assigned to receive either 5 days of AiTBS within 10 days (6 sessions per day) or 10 consecutive days of classic 10Hz rTMS intervention. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.
- Conditions
- Neuropathic Pain, Nociceptive Pain
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- AiTBS, rTMS, Neuropathic pain
- Medical subject headings
- Neuralgia, Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
Patients in the AiTBS group received 5 consecutive days of AiTBS treatment, with 6 sessions of iTBS interventions per day (1800 pulses per trial, with a 50-minute interval between trials). Patients in the 10Hz rTMS group received 10 consecutive days of 10Hz rTMS treatment within 10 days, with 1500 pulses per day, totaling 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| AiTBS group | Experimental | Eligible patients were receive 5 days of AiTBS on left M1 within 10 days. Clinical and neurophysiological assessments were performed at baseline and after the last sessions. Receives: Device: Repetitive transcranial magnetic stimulation |
| 10Hz rTMS | Active comparator | Patients were assigned to receive 10 consecutive days of classic 10Hz rTMS intervention on left M1. Clinical and neurophysiological assessments were performed at baseline and after the last sessions. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)".
The individual being evaluated marks a point on the line that corresponds to their current experience. The score is determined by measuring the distance from this mark to the "0" end, converted into a numerical value ranging from 0 to 10 (where each centimeter equals 1 point). Higher scores indicate a stronger intensity of the experience.
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
Secondary outcomes (6)
short-form McGill Pain Questionnaire (SF-MPQ)
The Short-Form McGill Pain Questionnaire (SF-MPQ) is a concise, widely used tool designed to assess the nature and intensity of pain in a efficient manner.
Key Components:
- Sensory pain descriptors (11 items): These words capture the physical qualities of pain, such as "throbbing," "burning," "aching," and "sharp." Respondents rate each on a scale of 0 (none) to 3 (severe).
- Affective pain descriptors (4 items): These reflect the emotional aspects of pain, including "tiring," "fearful," "punishing/cruel," and "worrying." They are also rated 0-3.
- Visual Analog Scale (VAS): A 10-centimeter line with endpoints labeled "no pain" and "worst imaginable pain." Patients mark a point along the line to indicate their pain intensity.
- Present Pain Intensity (PPI): A 6-point scale (0-5) ranging from "no pain" (0) to "excruciating" (5), used to rate the current level of pain.
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
7-item pain interference scale of the Brief Pain Inventory (BPI)
- Items assessed: The 7 items evaluate how pain interferes with:
- General activity
- Mood
- Walking ability
- Normal work (including both work outside the home and housework)
- Relationships with others
- Sleep
- Enjoyment of life
- Rating scale: Each item is rated on an 11-point numerical scale (0 = "does not interfere" to 10 = "interferes completely"), based on the past 24 hours.
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Patient Global Impression of Change (PGIC)
- Single-item structure: It consists of a single question that asks patients to rate how much their condition has changed since a specified baseline (e.g., "Since starting treatment, how would you rate your overall change in pain?").
- 7-point response scale: Responses range from "very much improved" (score 1) to "very much worse" (score 7), with intermediate options including "much improved," "minimally improved," "no change," "minimally worse," and "much worse."
- Subjective and holistic: It captures the patient's personal, global judgment rather than focusing on specific symptoms, reflecting their integrated experience of change.
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The 17-item Hamilton Depression Rating Scale (HAMD-17)
It includes 17 items covering core depressive symptoms and related manifestations, mainly involving the following dimensions:
- Emotional symptoms: Such as depressed mood, feelings of guilt, suicidal ideation, etc.
- Somatic symptoms: Including difficulty falling asleep, difficulty maintaining sleep, early awakening, reduced work and interests, retardation (psychomotor), agitation (psychomotor), somatic anxiety, gastrointestinal symptoms, general symptoms, sexual symptoms, etc.
- Other related symptoms: Such as weight loss, insight, delusional or obsessive symptoms, depersonalization or derealization, paranoid symptoms, compulsive symptoms, etc. (Some items vary slightly according to versions, with the core being emotional and somatic manifestations related to depression).
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Beck Depression Inventory-II (BDI-II)
The Beck Depression Inventory-II (BDI-II) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents.
It consists of 21 items, each describing a specific depressive symptom (e.g., sadness, loss of interest, guilt, fatigue, sleep disturbances, appetite changes).
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
TMS-EEG
TMS-EEG (Transcranial Magnetic Stimulation-Electroencephalography) is a combined neuroimaging technique that synchronously uses TMS to non-invasively stimulate specific brain regions and EEG to record the brain's electrical activity responses to this stimulation.
Measured: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start12 Sep 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic Pain, Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Yan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148388
- Sponsor's protocol ID
- 2024-0669
- Acronym
- AiTBS
- Status last verified
- Jul 2025
- First submitted
- 4 Aug 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain
- ClinicalTrials.gov ID
- NCT07148388
- Acronym / sponsor ID
- AiTBS / 2024-0669
- Conditions
- Neuropathic Pain, Nociceptive Pain
- Keywords
- AiTBS, rTMS, Neuropathic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Aug 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.
The present study was designed to be the first to evaluate the efficacy of the AiTBS protocol to relieve neuropathic pain in a therapeutic setting, i.e. with repeated stimulation sessions. The investigator directly compared the analgesic efficacy of AiTBS versus conventional 10-Hz rTMS delivered to the left M1. In addition to pain experiences, The investigator examined the effects of intervention on corticospinal excitability that assessed by TMS-EEG. The working hypothesis was that AiTBS would result in larger analgesic and significant cortical excitability changes compared to 10-Hz rTMS.
Eligible patients were randomly assigned to receive either 5 days of AiTBS within 10 days (6 sessions per day) or 10 consecutive days of classic 10Hz rTMS intervention. Clinical and neurophysiological assessments were performed at baseline and after the last sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AiTBS group | Experimental | Device: Repetitive transcranial magnetic stimulationEligible patients were receive 5 days of AiTBS on left M1 within 10 days. Clinical and neurophysiological assessments were performed at baseline and after the last sessions. |
| 10Hz rTMS | Active comparator | Device: Repetitive transcranial magnetic stimulationPatients were assigned to receive 10 consecutive days of classic 10Hz rTMS intervention on left M1. Clinical and neurophysiological assessments were performed at baseline and after the last sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- IASP diagnosis of peripheral neuropathic pain;
- At least three months after the onset of pain;
- At least moderate pain intensity (≥ 3 assessed by VAS or NRS);
- 18 years or older;
- Stable medical treatment from 2 weeks before allocation to the end of the trial;
Key exclusion criteria (6 listed)
- Contradictions to TMS treatment, such as metal implants or seizure;
- Serious psychiatric disorder (Hamilton Depression Rating Scale score ≥ 35 or Hamilton Anxiety Rating Scale score ≥ 29);
- Aphasia or cognitive disorders (Mini mental state examination ≤ 24);
- Severe clinical disorders caused by tumor or other conditions;
- Severe cardiopulmonary dysfunction or extreme weakness;
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationPatients in the AiTBS group received 5 consecutive days of AiTBS treatment, with 6 sessions of iTBS interventions per day (1800 pulses per trial, with a 50-minute interval between trials). Patients in the 10Hz rTMS group received 10 consecutive days of 10Hz rTMS treatment within 10 days, with 1500 pulses per day, totaling 15 minutes. | Device | 10Hz rTMS, AiTBS group |
Primary outcome
Visual analogue scale
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
It typically consists of a 10-centimeter straight line, with two endpoints representing extreme states of the measured experience. For example, when assessing pain, one end is labeled "0 (no pain at all)" and the other end "10 (worst pain imaginable, unbearable)". The individual being evaluated marks a point on the line that corresponds to their current experience. The score is determined by measuring the distance from this mark to the "0" end, converted into a numerical value ranging from 0 to 10 (where each centimeter equals 1 point). Higher scores indicate a stronger intensity of the experience.
6 secondary outcomes
short-form McGill Pain Questionnaire (SF-MPQ)
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
7-item pain interference scale of the Brief Pain Inventory (BPI)
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Patient Global Impression of Change (PGIC)
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The 17-item Hamilton Depression Rating Scale (HAMD-17)
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Beck Depression Inventory-II (BDI-II)
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
TMS-EEG
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group
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 26 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Neuropathic Pain, Nociceptive Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. 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 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. 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 Ying Liu (86-15595512306, 350373328@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale (time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention). 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 26 Jan 2026.