Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-12

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Accelerated Theta Burst in Chronic Pain: A Biomarker Study

NCT03984201

Chronic Pain

WITHDRAWN NA

Transcranial Magnetic Stimulation and/or Neurofunctional Electrical Acupuncture in Myofascial Chronic Pain Patients

NCT02381171

Myofascial Pain Syndromes

UNKNOWN NA

The Effect of Intermittent Theta Burst Stimulation on Brain Characteristics, Pain Intensity, and Cognitive Functions in Older People with Chronic Musculoskeletal Pain.

NCT06709963

Chronic Non-Specific Low Back Pain Chronic Knee Pain Chronic Musculoskeletal Pain

RECRUITING NA

High Frequency Impulse Therapy for Neuropathic Pain in NMOSD

NCT04614454

Neuromyelitis Optica

COMPLETED PHASE2

Impact of Vibrating Device Distraction on Mechanical Pain Thresholds Induced by Needle Sham

NCT06271642

Pain Anxiety

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuropathic Pain, Nociceptive Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AiTBS group

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.

Group Type EXPERIMENTAL

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.

10Hz rTMS

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.

Group Type ACTIVE_COMPARATOR

Repetitive transcranial magnetic stimulation

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Repetitive transcranial magnetic stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No