Effects of Prolonged Continuous Theta Burst Stimulation on Pain and Neural Excitability

NCT ID: NCT05852067

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-07-01

Brief 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. 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).

Conditions

pcTBS; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Active stimulation of M1

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.

Group Type: EXPERIMENTAL

pcTBS of M1

Intervention Type: DEVICE

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 stimulation

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

Group Type: SHAM_COMPARATOR

SHAM stimulation

Intervention Type: DEVICE

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

Interventions

pcTBS of M1

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

Intervention Type: DEVICE

SHAM stimulation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1) 18-65 years of age; 2) physical and mental health, free of chronic pain (through interviews and McGill questionnaires); 3) Right-handed

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

min yan, prof.

Role: STUDY_CHAIR

The second affiliated hospital of Zhejiang University hangzhou

Locations

The second affiliated hospital of Zhejiang University hangzhou

Hangzhou, , China

Countries

China

Central Contacts

chaomin wu, doctor

Role: CONTACT

cmwu@zju.edu.cn

15990027747

min yan, prof.

Role: CONTACT

zryanmin@zju.edu.cn

Facility Contacts

MIN YAN

Role: primary

zryanmin@zju.edu.cn

Other Identifiers

2023-0276

Identifier Type: -

Identifier Source: org_study_id