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A Study on the Efficacy of Dual-Carrier-Frequency Transcranial Alternating Current Stimulation Modulating the Hippocampus for the Treatment of Chronic Non-Specific Low Back Pain

16. září 2026 aktualizováno: Qilu Hospital of Shandong University

This is a single-center, randomized, double-blind, sham-controlled trial evaluating dual-carrier-frequency transcranial alternating current stimulation targeting the hippocampus in 60 patients with chronic non-specific low back pain. Participants will be randomized into four groups: active stimulation, active stimulation with iTBS, superficial stimulation control, and sham control. All groups will receive standard rehabilitation. The intervention is 20 minutes per session, 5 sessions weekly for 2 weeks (10 sessions total).

The primary objective is to assess improvements in pain intensity (VAS) and emotional symptoms (anxiety, depression) at week 2. Exploratory objectives include examining functional connectivity changes between the hippocampus and prefrontal/sensory cortices using fMRI, MEG, and fNIRS, and correlating these with clinical improvements.

Outcomes include VAS (primary), McGill Pain Questionnaire, HAMA, HAMD, ODI, CSI, PSQI, and objective measures (brain imaging, EEG, EMG). Assessments occur at baseline (T0), post-first stimulation (T1), mid-treatment (T2), treatment end (T3), and 2-week follow-up (T4).

Linear mixed-effects models will be used for analysis with multiple comparison correction. This study aims to provide evidence for hippocampal-targeted neuromodulation in chronic non-specific low back pain.

Přehled studie

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

    • Shandong
      • Jinan, Shandong, Čína, 250000
        • Nábor
        • Qilu hospital, Jinan, Shangdong
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Age between 18 and 80 years;
  2. Meets the diagnostic criteria for non-specific low back pain as specified in the Chinese Clinical Guidelines for the Diagnosis and Treatment of Non-specific Low Back Pain (2022) ;
  3. Diagnosed with chronic non-specific low back pain within the past 3 months, or pain located between T12 and the gluteal fold for at least half of the days within the past 6 months;
  4. VAS score ≥ 3 (Visual Analogue Scale, 0-10);
  5. Mechanical pain induced by posture, activity, and movement (e.g., flexion and functional movement tasks);
  6. Voluntarily agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

  1. Clear etiology of specific low back pain, such as vertebral fracture, severe spinal cord/nerve root compression symptoms (progressive neurological deficit), spinal infection, tumor, ankylosing spondylitis, etc.;
  2. Prior major lumbar surgery or implants (e.g., internal fixation, spinal cord stimulation devices, etc.), or recent (within 3 months) invasive analgesic treatments such as nerve blocks or radiofrequency ablation;
  3. Contraindications to MEG or MRI, including the presence of ferromagnetic metal implants in the body (e.g., cardiac pacemakers, hearing aids, carotid artery stents, etc.), claustrophobia that precludes MEG examination, or failed MEG acquisition;
  4. History of severe cardiovascular disease, epilepsy, or other conditions that contraindicate electrical stimulation;
  5. Pregnancy or lactation;
  6. Cognitive impairment, psychiatric disorders, or other conditions that prevent understanding or compliance with the study procedures;
  7. Rheumatic diseases, connective tissue diseases, or diabetes.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: TI Group

Interference currents of 2 kHz and 2.010 kHz are delivered through scalp electrodes to produce a 10 Hz modulation effect in the right hippocampus. The stimulation current is gradually increased from 0.5 mA to 2 mA, and electrode placement is optimized using a head model. A total of 10 sessions are administered (5 sessions per week for 2 weeks), with routine pain rehabilitation performed immediately after each session.

Dual-carrier-frequency transcranial alternating current stimulation is based on the interference principle. Two pairs of carrier-frequency alternating currents with slightly different frequencies are applied to the scalp. After intracranial superposition, the nonlinear response of biological tissues generates a low-frequency envelope-modulated electric field in deep brain regions. This interference electric field oscillates periodically at the difference between the two carrier frequencies, enabling entrainment and modulation of neuronal rhythms in deep structures. This distinguishes it from conventional transcranial electrical stimulation, in which electric field intensity decays exponentially with depth, predominantly affecting superficial cortical layers and having limited efficacy in modulating deep nuclei.

In terms of safety, this technique is a non-invasive stimulation method. Adverse effects are limited to mild tingling or itching at the electrode contact sites, indicating favo

Ostatní jména:
  • Temporal interference (TI)
Aktivní komparátor: TI-iTBS Group

In addition to the parameters used in the TI group, an intermittent theta-burst stimulation (iTBS) pattern is superimposed. All other parameters, including current intensity, target region, treatment frequency, total course, and subsequent rehabilitation, are identical to those of the TI group.

Dual-carrier-frequency transcranial alternating current stimulation is based on the interference principle. Two pairs of carrier-frequency alternating currents with slightly different frequencies are applied to the scalp. After intracranial superposition, the nonlinear response of biological tissues generates a low-frequency envelope-modulated electric field in deep brain regions. This interference electric field oscillates periodically at the difference between the two carrier frequencies, enabling entrainment and modulation of neuronal rhythms in deep structures. This distinguishes it from conventional transcranial electrical stimulation, in which electric field intensity decays exponentially with depth, predominantly affecting superficial cortical layers and having limited efficacy in modulating deep nuclei.

In terms of safety, this technique is a non-invasive stimulation method. Adverse effects are limited to mild tingling or itching at the electrode contact sites, indicating favo

Ostatní jména:
  • Temporal interference (TI)
Aktivní komparátor: tES Group

Cortical electrical stimulation is applied, with electrodes primarily placed over the primary somatosensory cortex (S1 region) to activate superficial cortical layers and modulate the sensorimotor network. Stimulation intensity is set within the tolerated range. Each session lasts 20 minutes, and the treatment frequency, total course, and subsequent rehabilitation are consistent with those of the previous two groups.

Cortical electrical stimulation is a neuromodulation technique in which electrodes are placed on the surface of the cerebral cortex or over the dura mater to deliver weak electrical currents for direct modulation of local neuronal electrical activity. By either exciting or inhibiting neuronal firing in specific cortical regions, it can regulate functional brain networks and is commonly used in studies on brain function mapping, neurorehabilitation, and pain modulation.

Falešný srovnávač: Sham group

Electrode placement and the operational procedures are identical to those of the TI group. However, the current output during the treatment is 0 mA, with only the onset and offset sensations of stimulation being simulated, and no effective frequency difference or envelope modulation is generated. The treatment course, frequency, and subsequent rehabilitation are the same as those of the other groups, aiming to maintain blinding without producing any neuromodulatory effects.

Dual-carrier-frequency transcranial alternating current stimulation is based on the interference principle. Two pairs of carrier-frequency alternating currents with slightly different frequencies are applied to the scalp. After intracranial superposition, the nonlinear response of biological tissues generates a low-frequency envelope-modulated electric field in deep brain regions. This interference electric field oscillates periodically at the difference between the two carrier frequencies, enabling entrainment and modulation of neuronal rhythms in deep structures. This distinguishes it from conventional transcranial electrical stimulation, in which electric field intensity decays exponentially with depth, predominantly affecting superficial cortical layers and having limited efficacy in modulating deep nuclei.

In terms of safety, this technique is a non-invasive stimulation method. Adverse effects are limited to mild tingling or itching at the electrode contact sites, indicating favo

Ostatní jména:
  • Temporal interference (TI)

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Visual Analogue Scale (VAS)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A 100-mm visual analogue scale is used, with "0" indicating no pain and "10" indicating the worst possible pain; the subject marks the current pain level on the scale, and the distance (mm) from the left end is measured as the VAS score

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Ultrasound
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A high-frequency linear array ultrasound probe (≥10 MHz) is placed over the erector spinae and multifidus muscles; cross-sectional and longitudinal gray-scale images are acquired in standardized positions, and muscle thickness, cross-sectional area, and echo intensity are measured using image analysis software to assess morphological and structural changes

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Motion Sensors
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Inertial measurement unit (IMU) sensors integrating tri-axial accelerometers, gyroscopes, and magnetometers are attached to the subject's lumbar region and bilateral lower limbs; continuous data on acceleration, angular velocity, and orientation are collected during standardized walking and trunk movement tasks, and gait parameters, trunk range of motion, and symmetry indices are calculated using dedicated algorithms

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Central Sensitization Inventory (CSI)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A 25-item self-administered questionnaire is used, with each item scored from 0 to 4 (never to always); the total score ranges from 0 to 100, with higher scores indicating a higher degree of central sensitization

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Magnetoencephalography (MEG)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A whole-head magnetoencephalography system is used to record spontaneous brain magnetic signals in a shielded room during the resting state; source localization algorithms are applied to reconstruct the magnetic signals from the scalp to the intracerebral source space, and spectral power and functional connectivity of the hippocampus and pain-related brain regions are assessed

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Functional Magnetic Resonance Imaging (fMRI)
Časové okno: Pre-enrollment (T0),end of the 2-week intervention (T3),

Blood oxygen level-dependent (BOLD) functional imaging is performed using a 3.0T or higher MRI scanner; the subject remains in a resting state during scanning, and functional connectivity is assessed by measuring the temporal synchronization of low-frequency BOLD signal oscillations between brain regions, with a focus on connectivity changes between the hippocampus, prefrontal cortex, and somatosensory cortex

Pre-enrollment (T0),end of the 2-week intervention (T3),
Functional Near-Infrared Spectroscopy (fNIRS)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A multi-channel functional near-infrared spectroscopy system is used, with optodes placed over the scalp regions corresponding to the prefrontal cortex and sensorimotor cortex; changes in oxygenated and deoxygenated hemoglobin concentrations are monitored in real time by measuring near-infrared light attenuation, reflecting regional cerebral functional activity.

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Surface Electromyography (sEMG)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Surface electrodes are placed symmetrically over the bilateral erector spinae and multifidus muscle bellies; sEMG signals are recorded during standardized functional movements (e.g., trunk flexion and extension), and after amplification, filtering and root mean square (RMS) processing, time-domain and frequency-domain parameters are extracted to assess muscle activation patterns and fatigue

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Depression Scale (HAMD)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

The 17-item version of the Hamilton Depression Scale is administered by a trained evaluator through a structured interview; the total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Hamilton Anxiety Scale (HAMA)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

The 14-item version of the Hamilton Anxiety Scale is administered by a trained evaluator through a structured interview; the total score ranges from 0 to 56, with higher scores indicating more severe anxiety symptoms.

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
McGill Pain Questionnaire (MPQ)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A standardized self-administered questionnaire comprising sensory, affective, and evaluative dimensions is used; the subject selects the most appropriate pain descriptors based on personal pain experience, and the Pain Rating Index (PRI) and Present Pain Intensity (PPI) scores are calculated

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Oswestry Disability Index (ODI)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A 10-item self-administered questionnaire (covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling) is used; each item is scored 0-5, and the sum is expressed as a percentage of the maximum possible score (0-100%), with higher percentages indicating more severe disability

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Pittsburgh Sleep Quality Index (PSQI)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)

A 19-item self-administered questionnaire comprising 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction) is used; each component is scored 0-3, and the sum yields a global PSQI score (0-21), with a score >5 indicating poor sleep quality

Pre-enrollment (T0), immediately after the first intervention (T1), mid-intervention (T2), end of the 2-week intervention (T3), and 2-week follow-up (T4)
Electroencephalography (EEG)
Časové okno: Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Scalp electroencephalography is recorded using the international 10-20 electrode placement system during both resting and task states; signals are amplified, filtered, and digitized, and power spectral density across frequency bands (δ, θ, α, β, γ) and EEG microstate features are extracted to assess changes in spontaneous neural electrical activity

Pre-enrollment (T0), immediately after the first intervention (T1), end of the 2-week intervention (T3), and 2-week follow-up (T4)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

3. července 2026

Primární dokončení (Odhadovaný)

24. září 2029

Dokončení studie (Odhadovaný)

24. září 2029

Termíny zápisu do studia

První předloženo

21. července 2026

První předloženo, které splnilo kritéria kontroly kvality

16. září 2026

První zveřejněno (Aktuální)

21. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. září 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Plán pro data jednotlivých účastníků (IPD)

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NE

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Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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