The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Location status: Recruiting
NCT Number: NCT07148388
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Hangzhou, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
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.
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Short-Form McGill Pain Questionnaire (SF-MPQ) is a concise, widely used tool designed to assess the nature and intensity of pain in a efficient manner.
Key Components:
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
It includes 17 items covering core depressive symptoms and related manifestations, mainly involving the following dimensions:
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention
The Beck Depression Inventory-II (BDI-II) is a widely used self-report questionnaire designed to assess the severity of depressive symptoms in adults and adolescents.
It consists of 21 items, each describing a specific depressive symptom (e.g., sadness, loss of interest, guilt, fatigue, sleep disturbances, appetite changes).
Time frame: Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group
TMS-EEG (Transcranial Magnetic Stimulation-Electroencephalography) is a combined neuroimaging technique that synchronously uses TMS to non-invasively stimulate specific brain regions and EEG to record the brain's electrical activity responses to this stimulation.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Effects and Mechanism of Accelerated Intermittent Theta Burst Stimulation on Neuropathic Pain
Acronym: AiTBS
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