High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety
A legfontosabb adatok
- Ki végzi
- Shenyang Medical College
- Hol
- Kína3 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 48 fő, tervezett
- Kezdés
- 2025. nov. 19.
- Várható befejezés
- 2027. jan. 12.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles
- Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles
- A regiszteradat frissítve
- 2026. november 3.
Ki vehet részt
- Életkor
- 18 év – 45 év
- Nem
- Csak nők
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 9 feltétel megnézéseKevesebb
Ki vehet részt
- (i) Female, aged 18-45 years, and right-handed
- (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation
- (iii) Not currently pregnant or in a state of missed miscarriage
- (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17
Ki nem vehet részt
- (v) Other current major psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium. To preserve diagnostic homogeneity of the study sample, participants whose current primary diagnosis is another anxiety-related disorder will also be excluded, including panic disorder, social anxiety disorder, separation anxiety disorder, specific phobia, obsessive-compulsive and related disorders, and trauma- and stressor-related disorders; Current use of psychotropic medication at screening, or continuous use within the 4 weeks before screening of antidepressants, anxiolytics, antipsychotics, mood stabilizers, or sedative-hypnotics, in order to minimize hemodynamic confounding
- (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy
- (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders
- (ii) Unstable blood pressure (systolic >180 mmHg or <90 mmHg)
- (iv) Significant suicide risk
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 45 év között vagy?
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are:
A teljes eredeti leírásKevesebb
Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation?
Does 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation?
Researchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity.
Participants will:
Undergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC;
Have continuous electrocardiography (ECG) recordings collected during the entire stimulation session;
Complete clinical and psychiatric assessments before participation.
A vizsgálat 2 csoportja
- real rTMS groupMár használt kezelés, összehasonlításként
Participants in this arm will receive active repetitive transcranial magnetic stimulation (rTMS) delivered to the right dorsolateral prefrontal cortex (DLPFC). In Stage 1, the stimulation protocol consists of 20 consecutive cycles of low-frequency (1 Hz) rTMS at 120% of the resting motor threshold (RMT), with each cycle comprising 40 seconds of stimulation followed by 20 seconds of rest. The total stimulation duration is approximately 20 minutes. Real stimulation is applied with the figure-of-eight coil positioned tangentially to the scalp. After completion of Stage 1 and the post-procedure safety observation period, participants may voluntarily enter a prespecified exploratory Stage 2 subgroup for 4 weeks of continued treatment and follow-up while remaining in their original randomized assignment. Participants who enter Stage 2 will continue to receive active stimulation under the same fixed-parameter framework; no re-randomization will be performed.
Kezelés: Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles
- sham rTMS groupSzínlelt kezelés, összehasonlításként
Participants in this arm will receive sham repetitive transcranial magnetic stimulation (rTMS) over the right dorsolateral prefrontal cortex (DLPFC). In Stage 1, the stimulation protocol mimics the active condition in timing and coil placement but involves tilting the coil at a 45-degree angle to the scalp, significantly attenuating magnetic field penetration. This approach preserves the auditory and tactile sensations of stimulation without producing cortical effects. The procedure consists of 20 consecutive cycles of sham stimulation, each comprising 40 seconds of simulated stimulation followed by 20 seconds of rest, lasting approximately 20 minutes in total. After completion of Stage 1 and the post-procedure safety observation period, participants may voluntarily enter a prespecified exploratory Stage 2 subgroup for 4 weeks of continued treatment and follow-up while remaining in their original randomized assignment. Participants who enter Stage 2 will continue to receive sham stimu
Kezelés: Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- High-intensity, Low-frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex for Acute Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Generalized Anxiety Disorder: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-rTMS-2)
- Illeszkedési kérdések
- Forrás: NCT07233278: ki vehet részt
- A regiszteradat frissítve
- 2026. november 3.