Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

Zhejiang University

Status: Enrolling

Conditions: Neuropathic Pain, Nociceptive Pain

Treatments: Device: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07148388

2024-0669

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

AiTBS group

Experimental group

Description:

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation

10Hz rTMS

Active Comparator group

Description:

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.

Treatment:

Device: Repetitive transcranial magnetic stimulation