Accelerated Intermittent Theta Burst Stimulation (AiTBS)on Neuropathic Pain

NCT07148388 | Recruiting

• 1 other identifier: 2024-0669
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

AiTBS, rTMS, Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

• The Patient Global Impression of Change (PGIC)

  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)

  Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

• The Beck Depression Inventory-II (BDI-II)

  Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention

Study Arms (2)

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.

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.

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation 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; AiTBS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Neuralgia; Nociceptive Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Ying Liu

CONTACT

86-15595512306; 350373328@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 29, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)