pcTBSNCT05852067
Effects of Prolonged Continuous Theta Burst Stimulation on Pain and Neural Excitability
A study testing pcTBS of M1 in people with pcTBS and Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Numerous studies have confirmed the analgesic effect of M1-rTMS on both induced pain and various chronic pains and subsequently found that pcTBS is more time-efficient and can produce the same or even stronger analgesic effect, however, its study in pathological pain h has not been thoroughly investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- pcTBS of M1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 1 Jul 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1) 18-65 years of age; 2) physical and mental health, free of chronic pain (through interviews and McGill questionnaires); 3) Right-handed
Who cannot join
- 1) inability to receive TMS interventions (e.g. pacemaker); 2) mental illness or suicidal tendencies; 3) history of previous seizures/epilepsy; 4) previous craniocerebral surgery for stroke or other reasons; 5) drug/substance dependence; 6) Inability to sit upright to cooperate with assessment and treatment; 7) Pregnancy or planning to become pregnant within half a year
Trial locations and contacts
1 site in 1 country.
min yan, prof. contact
China1 site
The second affiliated hospital of Zhejiang University hangzhou
Hangzhou
MIN YAN, zryanmin@zju.edu.cn
About this study
Official title: The Second Affiliated Hospital Zhejiang University School od Medicine
Numerous studies have confirmed the analgesic effect of M1-rTMS on both induced pain and various chronic pains and subsequently found that pcTBS is more time-efficient and can produce the same or even stronger analgesic effect, however, its study in pathological pain h has not been thoroughly investigated. Due to the dynamic nature of the injury sensory system, pain also exhibits a dynamic process, but there is a lack of specific methods or biomarkers to document this process. Surface electromyography (EMG) is a common technique used in rTMS studies to reflect changes in cortical excitability. In turn, both pain and rTMS interventions can cause changes and thus can be used as a potential biomarker to predict pain onset and progression. In addition, the number of sessions of rTMS treatment is an important factor influencing the analgesic effect of rTMS. In summary, this study intends to explore the best pain predictor by using a capsaicin-induced pain model in healthy volunteers, monitor the dynamic changes of cortical excitability index and VAS score before and after pcTBS intervention, and also verify the relationship between the number of pcTBS treatments and analgesic effect, to provide a new strategy for the prevention and treatment of neuropathic pain.
Read the detailed description
This study was a prospective, single-blind, sham-controlled, crossover-design trial. Each subject was randomized to receive 3 sessions of rTMS intervention, consisting of 2 consecutive pcTBS stimulations and 1 sham stimulation, with no less than 3 days between each session. The pain was induced by applying capsaicin to the dorsum t of the right hand and recording electromyographic (EMG) signals with surface electrodes on the right first interosseous muscle. Subjects received M1- pcTBS or sham stimulation (Sham) intervention at 40 minutes of capsaicin application (T40). Subjects' cortical excitability was measured at 5-minute intervals at baseline, 40 minutes after capsaicin application and pcTBS intervention, and pain perception was assessed at 10-minute intervals (each assessment to be performed at the end of the measurement).
- Being tested
- pcTBS of M1, SHAM stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pcTBS of M1Device
Prolonged continuous theta-burst stimulation (pcTBS) was administered to the left M1 at 80% RMT, consisting of a burst of 3 pulses given at 50 Hz repeated every 5 Hz. A total of 1,200 pulses were delivered with the TMS coil positioned in a posterior-anterior (PA) direction parallel to the midline
SHAM stimulationDevice
The Sham stimulation was delivered using the same pcTBS protocol, with the coil being flipped 90◦to the scalp so that the magnetic field would be delivered away from the scalp
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation of M1 | Experimental | pcTBS was administered to the left M1 at 80% resting motor threshold (RMT), consisting of a burst of 3 pulses given at 50 Hz repeated every 5 Hz. A total of 1,200 pulses were delivered with the TMS coil positioned in a posterior-anterior (PA) direction parallel to the midline. Receives: Device: pcTBS of M1 |
| SHAM stimulation | Sham comparator | The Sham stimulation was delivered using the same protocol, with the coil being orientated at 90° to the scalp so that the magnetic field would be delivered away from the scal Receives: Device: SHAM stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of pain intensity
pain intensity on a 10-cm visual analogue scale (VAS) extending from 0 (no pain) to 100 (maximal pain possible) at baseline and posttreatment of pcTBS stimulation
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Motor-evoked potential (MEP)
Corticospinal excitability was measured with MEP at rest of the first dorsal interosseous (FDI) muscle, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward)
Measured: through study completion, an average of 6 months
Cortical silent period (CSP)
Corticospinal excitability will be measured with CSP during a sustained voluntary FDI muscle contraction, A total of 20 single pulses were consecutively delivered to the hand region of the left M1 at 120% RMT (45° to the midline, handle pointing backward)
Measured: through study completion, an average of 6 months
pain intensity after two sessions of pcTBS
pain intensity on a 10-cm visual analogue scale (VAS) extending from 0 (no pain) to 100 (maximal pain possible) after two sessions of pcTBS
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 May 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for pcTBSStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- min yan, prof., Study chair, The second affiliated hospital of Zhejiang University hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852067
- Sponsor's protocol ID
- 2023-0276
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 10 May 2023
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Second Affiliated Hospital Zhejiang University School od Medicine
- ClinicalTrials.gov ID
- NCT05852067
- Acronym / sponsor ID
- 2023-0276
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 10 May 2023 (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.
Numerous studies have confirmed the analgesic effect of M1-rTMS on both induced pain and various chronic pains and subsequently found that pcTBS is more time-efficient and can produce the same or even stronger analgesic effect, however, its study in pathological pain h has not been thoroughly investigated. Due to the dynamic nature of the injury sensory system, pain also exhibits a dynamic process, but there is a lack of specific methods or biomarkers to document this process. Surface electromyography (EMG) is a common technique used in rTMS studies to reflect changes in cortical excitability. In turn, both pain and rTMS interventions can cause changes and thus can be used as a potential biomarker to predict pain onset and progression. In addition, the number of sessions of rTMS treatment is an important factor influencing the analgesic effect of rTMS. In summary, this study intends to explore the best pain predictor by using a capsaicin-induced pain model in healthy volunteers, monitor the dynamic changes of cortical excitability index and VAS score before and after pcTBS intervention, and also verify the relationship between the number of pcTBS treatments and analgesic effect, to provide a new strategy for the prevention and treatment of neuropathic pain.
Detailed description
This study was a prospective, single-blind, sham-controlled, crossover-design trial. Each subject was randomized to receive 3 sessions of rTMS intervention, consisting of 2 consecutive pcTBS stimulations and 1 sham stimulation, with no less than 3 days between each session. The pain was induced by applying capsaicin to the dorsum t of the right hand and recording electromyographic (EMG) signals with surface electrodes on the right first interosseous muscle. Subjects received M1- pcTBS or sham stimulation (Sham) intervention at 40 minutes of capsaicin application (T40). Subjects' cortical excitability was measured at 5-minute intervals at baseline, 40 minutes after capsaicin application and pcTBS intervention, and pain perception was assessed at 10-minute intervals (each assessment to be performed at the end of the measurement).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation of M1 | Experimental | Device: pcTBS of M1pcTBS was administered to the left M1 at 80% resting motor threshold (RMT), consisting of a burst of 3 pulses given at 50 Hz repeated every 5 Hz. A total of 1,200 pulses were delivered with the TMS coil positioned in a posterior-anterior (PA) direction parallel to the midline. |
| SHAM stimulation | Sham comparator | Device: SHAM stimulationThe Sham stimulation was delivered using the same protocol, with the coil being orientated at 90° to the scalp so that the magnetic field would be delivered away from the scal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) 18-65 years of age; 2) physical and mental health, free of chronic pain (through interviews and McGill questionnaires); 3) Right-handed
Key exclusion criteria (1 listed)
- 1) inability to receive TMS interventions (e.g. pacemaker); 2) mental illness or suicidal tendencies; 3) history of previous seizures/epilepsy; 4) previous craniocerebral surgery for stroke or other reasons; 5) drug/substance dependence; 6) Inability to sit upright to cooperate with assessment and treatment; 7) Pregnancy or planning to become pregnant within half a year
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 |
|---|---|---|
| pcTBS of M1Prolonged continuous theta-burst stimulation (pcTBS) was administered to the left M1 at 80% RMT, consisting of a burst of 3 pulses given at 50 Hz repeated every 5 Hz. A total of 1,200 pulses were delivered with the TMS coil positioned in a posterior-anterior (PA) direction parallel to the midline | Device | Active stimulation of M1 |
| SHAM stimulationThe Sham stimulation was delivered using the same pcTBS protocol, with the coil being flipped 90◦to the scalp so that the magnetic field would be delivered away from the scalp | Device | SHAM stimulation |
Primary outcome
change of pain intensity
Time frame: through study completion, an average of 6 months
pain intensity on a 10-cm visual analogue scale (VAS) extending from 0 (no pain) to 100 (maximal pain possible) at baseline and posttreatment of pcTBS stimulation
3 secondary outcomes
Motor-evoked potential (MEP)
Time frame: through study completion, an average of 6 months
Cortical silent period (CSP)
Time frame: through study completion, an average of 6 months
pain intensity after two sessions of pcTBS
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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.
min yan, prof. contact
min yan, prof. study chair
The second affiliated hospital of Zhejiang University hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pcTBS of M1 in people with pcTBS and 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 May 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact chaomin wu, doctor (15990027747, cmwu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of pain intensity (time frame: through study completion, an average of 6 months). 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 May 2023.