Neuropathic Pain, Nociceptive Pain
Conditions
Keywords
AiTBS, rTMS, Neuropathic pain
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.
Interventions
DEVICERepetitive 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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| short-form McGill Pain Questionnaire (SF-MPQ) | 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: * Sensory pain descriptors (11 items): These words capture the physical qualities of pain, such as "throbbing," "burning," "aching," and "sharp." Respondents rate each on a scale of 0 (none) to 3 (severe). * Affective pain descriptors (4 items): These reflect the emotional aspects of pain, including "tiring," "fearful," "punishing/cruel," and "worrying." They are also rated 0-3. * Visual Analog Scale (VAS): A 10-centimeter line with endpoints labeled "no pain" and "worst imaginable pain." Patients mark a point along the line to indicate their pain intensity. * Present Pain Intensity (PPI): A 6-point scale (0-5) ranging from "no pain" (0) to "excruciating" (5), used to rate the current level of pain. |
| 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 | * Items assessed: The 7 items evaluate how pain interferes with: * General activity * Mood * Walking ability * Normal work (including both work outside the home and housework) * Relationships with others * Sleep * Enjoyment of life * Rating scale: Each item is rated on an 11-point numerical scale (0 = "does not interfere" to 10 = "interferes completely"), based on the past 24 hours. |
| The Patient Global Impression of Change (PGIC) | Day1(Baseline), day 5 in AiTBS group, day 10 in 10Hz group, 1 month after intervention | * Single-item structure: It consists of a single question that asks patients to rate how much their condition has changed since a specified baseline (e.g., "Since starting treatment, how would you rate your overall change in pain?"). * 7-point response scale: Responses range from "very much improved" (score 1) to "very much worse" (score 7), with intermediate options including "much improved," "minimally improved," "no change," "minimally worse," and "much worse." * Subjective and holistic: It captures the patient's personal, global judgment rather than focusing on specific symptoms, reflecting their integrated experience of change. |
| 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 | It includes 17 items covering core depressive symptoms and related manifestations, mainly involving the following dimensions: * Emotional symptoms: Such as depressed mood, feelings of guilt, suicidal ideation, etc. * Somatic symptoms: Including difficulty falling asleep, difficulty maintaining sleep, early awakening, reduced work and interests, retardation (psychomotor), agitation (psychomotor), somatic anxiety, gastrointestinal symptoms, general symptoms, sexual symptoms, etc. * Other related symptoms: Such as weight loss, insight, delusional or obsessive symptoms, depersonalization or derealization, paranoid symptoms, compulsive symptoms, etc. (Some items vary slightly according to versions, with the core being emotional and somatic manifestations related to depression). |
| The Beck Depression Inventory-II (BDI-II) | 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). |
| TMS-EEG | 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. |
Countries
China
Contacts
CONTACTYing Liu
Outcome results
None listed