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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| short-form McGill Pain Questionnaire (SF-MPQ) | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Liu | Contact | 86-15595512306 | 350373328@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059226 | Nociceptive Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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| 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) | It includes 17 items covering core depressive symptoms and related manifestations, mainly involving the following dimensions:
| Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention |
| The Beck Depression Inventory-II (BDI-II) | 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). | Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention |
| TMS-EEG | 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. | Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |