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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

Neurostimulation Versus Therapy for Problems With Emotions

A legfontosabb adatok

Ki végzi
Duke University
Hol
Durham (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
240 fő, tervezett
Kezdés
2023. máj. 15.
Várható befejezés
2027. dec. 1.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
  • electrical scalp stimulation
  • Cognitive Restructuring
  • Emotional Awareness Training
A regiszteradat frissítve
2026. március 4.

Ki vehet részt

Életkor
18 év – 55 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 29 feltétel megnézéseKevesebb

Ki vehet részt

  • age 18 to 55
  • elevated overall score on Difficulties with Emotion Regulation Scale (DERS total score >=90)
  • has been in the same type of psychotherapy (including none) for the last 4 weeks/1mo (*except for current CBT) and is willing to stay on the same regimen throughout the study
  • low self-reported use of cognitive restructuring (ERQ restructuring subscale average score < 4.7)
  • meets criteria for at least one mood (including Bipolar II w/o current hypomania), anxiety, stressor, OCD, Impulse Control, ADHD, or eating DSM-5 disorder (except exclusionary diagnoses such as severe anorexia). Note: Both current or partial remission of the disorder will be ok for inclusion into the study
  • verbal agreement to maintain dose of prescribed psychotropic medication (if any) constant throughout the study, provided they are stable on it for the past 4 weeks (except exclusion medication and except if there is a medical emergency requiring changes in medication)
  • Naïve to rTMS

Ki nem vehet részt

  • started/changed psychotropic medications in the prior 4 weeks, or plans to change medication during the study
  • Wellbutrin >300mg per day or on daily stimulant/ADHD medications above the recommended FDA daily recommendations
  • use of investigational drug or devices within 4 weeks of screening
  • cochlear implants
  • has had CBT in the past 4 weeks or plans to start therapy during the study
  • meets diagnostic criteria for current or history of psychotic disorder, or psychotic features,
  • meets diagnostic criteria for Bipolar I disorder
  • meets diagnostic criteria on SCID5 for current alcohol or substance use disorder (moderate and high severity) or meets past history of severe alcohol use disorder
  • current uncontrolled anorexia or other condition requiring hospitalization
  • current serious medical illness, including current severe migraine headaches
  • history of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesions that are contraindications for TMS, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator), have left elbow/hand/wrist tendonitis
  • conditions associated with increased intracranial pressure, space occupying brain lesion (considered significant and unsafe for TMS by the study MD), transient ischemic attack, cerebral aneurysm, dementia, Parkinson's or Huntington's disease, multiple sclerosis
  • current hypomania (Note: Bipolar II w/o current hypomanic episode is ok for inclusion)
  • unable to read, blind, or deaf, or unwilling to give consent
  • non-English speaker,
  • verbal IQ < 90 on the North American Adult Reading Test (NART)
  • high risk for suicide defined as either having attempted suicide in past 6 months or reporting current suicidal ideation that includes a method, plan, or intent to die
  • Pregnancy
  • metal in body that would exclude them from the MRI scan; severe claustrophobia
  • is a prisoner or in police custody at time of screening, or has pending court case jeopardizing the participation in the study
  • has had TMS in their lifetime
  • weighs over 300 pounds (could not fit in MRI scanner)

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 55 év között vagy?

Helyszínek itt: Egyesült Államok

  • Duke University Medical CenterDurham, Egyesült ÁllamokContact: Andrada D Neacsiu, PhDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The primary goal of this clinical trial is to evaluate the unique neural and behavioral effects of a one-session training combining emotion regulation skills training, with excitatory repetitive transcranial magnetic stimulation (rTMS) over the dorsolateral prefrontal cortex (dlPFC). The secondary aim is to identify key changes in the emotion regulation neural network following the combined intervention versus each of the components alone. The third aim is to explore personalized biomarkers for response to emotion regulation training.

A teljes eredeti leírásKevesebb

Participants will undergo brain imaging while engaging in an emotional regulation task. Participants will be randomly assigned to learn one of two emotion regulation skills. Participants will be reminded of recent stressors and will undergo different types of neurostimulation, targeted using fMRI (functional MRI) results. Participants who may practice their emotion regulation skills during neurostimulation in a one-time session. Following this training, participants will undergo another fMRI and an exit interview to assess for immediate neural and behavioral changes. Measures of emotion regulation will be assessed at a one week and a one month follow up visit.

A vizsgálat 3 csoportja

  • Cognitive Restructuring + Repetitive Transcranial Magnetic Stimulation (rTMS)A vizsgált kezelés

    Group 1 (G1)- 80 eligible participants will receive training in Cognitive Restructuring (CR). These participants will use CR while receiving rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

    Kezelés: Repetitive Transcranial Magnetic Stimulation (rTMS) és Cognitive Restructuring

  • Cognitive Restructuring + scalp electrical stimulationMár használt kezelés, összehasonlításként

    Group 2 (G2) - 80 eligible participants will receive training in CR. These participants will use CR while receiving scalp electrical stimulation over their individual dlPFC target and will partake in short term and long term follow up testing.

    Kezelés: electrical scalp stimulation és Cognitive Restructuring

  • Emotional Awareness Training + Repetitive Transcranial Magnetic Stimulation (rTMS)Már használt kezelés, összehasonlításként

    Group 3 (G3) - 80 eligible participants will receive emotional awareness training. These participants will receive rTMS over their individual dlPFC target and will partake in short term and long term follow up testing.

    Kezelés: Repetitive Transcranial Magnetic Stimulation (rTMS) és Emotional Awareness Training

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Neurostimulation Enhanced Cognitive Restructuring for Transdiagnostic Emotional Dysregulation: A Component Analysis
Illeszkedési kérdések
Forrás: NCT05712057: ki vehet részt
A regiszteradat frissítve
2026. március 4.