Identifying Electrophysiological Targets for Transcranial Magnetic Stimulation in Cocaine Use Disorder

Обзор

The purpose of this study is to assess effects of intermittent theta burst stimulation (iTBS) to left dorsolateral prefrontal cortex (dlPFC) and dorsomedial prefrontal cortex (dmPFC) compared to sham on electrophysiological indices of reward sensitivity and motivated attention in adults with cocaine use disorder.

Вмешательства

• Устройство TMS to dmPFC
  TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dmPFC, approximately 25% of the nasion-inion distance or Talairah coordinates X 0 Y+60 Z+60 will be measured. The first session will begin with the acquisition of the resting motor threshold (rMT) on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will las
• Устройство TMS to dlPFC
  TMS will be delivered with a MagVenture Mag Pro R30 with the Cool-B70 A/P coil with active liquid cooling and active/sham sides. For dlPFC, position F3 will be measured, using probabilistic EEG placement. The first session will begin with the acquisition of the resting motor threshold on the contralateral hand. iTBS (triplet 50 Hz bursts, repeated at 5 Hz, 2 sec on and 8 sec off; 600 pulses per session) will be delivered at 110% of the rMT and will last 3 minutes. The stimulation will start at a
• Устройство Sham iTBS
  Sham TMS will be delivered with the sham side of the MagVenture Cool B70 A/P coil. The software will be pre-programmed by a staff member that will not be involved in data analysis or collection for blinding purposes. The sham stimulation will match the number of pulses and length of time as the active condition and each participant will receive 3 sessions with a 15-20 min interval between sessions.

Первичные конечные точки

• Change in the amplitude of the Reward Positivity (RewP) component in microvolts in response to feedback on the Doors Task [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]
• Change in the amplitude of the Late Positive Potential (LPP) in microvolts in response to visual stimuli on the Picture Viewing Task. [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]

Вторичные конечные точки (5)

• Change in craving as assessed by the Minnesota Cocaine Craving Scale (MCCS) [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]
• Change in pain as assessed by the Visual Analogue Scale [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]
• Change in cognitive function as assessed by the The Montreal Cognitive Assessment (MoCA) [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]
• Change in behavioral reward learning as assessed by the Pavlovian Go/No-Go task [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]
• Change in Anhedonia as assessed by the Snaith Hamilton Pleasure Scale (SHAPS) [Срок оценки: Baseline(before iTBS session),immediately after iTBS session]

Критерии участия

Критерии включения

• non-treatment-seeking adults
• meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for current cocaine use disorder of at least moderate severity (≥ 4 symptoms)
• have at least 1 positive urine Benzoylecgonine (BE) specimen (≥ 300 ng/mL) during intake
• be able to understand the consent form and provide written informed consent
• be able to provide the following verifiable information for a minimum of 2 contact persons: full legal name,email address, local mailing address, and as applicable, home, work, and cell phone numbers

Критерии исключения

• current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, or nicotine
• in the opinion of the principal investigator (PI), the presence of any medical, neurological, psychiatric, or physical condition, disease, or illness that, may: (a) compromise interfere, limit, effect or reduce the subject's ability to complete the study; or (b) adversely impact the safety of the subject or the integrity of the data
• has current or recent (within 3 months of potential enrollment) suicidal ideation, suicidal behavior, homicidal ideation or a homicidal plan sufficient to raise subject safety concerns based on the following assessments according to the PI:

• Structured Clinical Interview for DSM-5 (SCID-5)
• Columbia Suicide Severity Rating Scale (C-SSRS) Screener - Answers YES to Questions 3, 4, 5, or 6
• Assault \& Homicidal Danger Assessment Tool - Key to Danger > 1
• medical implants contraindicating TMS (i.e., aneurysm clips or coils, stents, implanted stimulators, implanted vagus nerve or deep brain stimulators, implanted electrical devices such as pacemakers or medication pumps electrodes for monitoring brain activity, cochlear implants for hearing, any magnetic implants, bullet fragments, any other metal device or object implanted in your body closer than 30 cm from the coil)
• history of brain surgery
• history of an intracranial lesion or any medical or neurological diagnosis/condition associated with increased intracranial pressure (i.e., Idiopathic Intracranial Hypertension/Pseudotumor Cerebri) OR any of the following symptoms within 30 days of enrollment: headaches > 15 days/month, loss of vision or decreased vision
• moderate-to-severe heart disease
• history of stroke
• is taking any antidepressant or antipsychotic medication at a dose above the maximum recommended dose or at a dose deemed to be potentially unsafe according to the PI; has taken any of the following medications, which are known to increase the risk of seizures, within 1 week of study enrollment; or does not agree to abstain from taking the following medications during study participation:

• clozapine137
• chlorpromazine137
• bupropion
• clomipramine hydrochloride
• amoxapine
• maprotiline hydrochloride
• diphenhydramine
• stimulants other than cocaine including the following:

• Dextroamphetamine and amphetamine
• Dextroamphetamine
• Lisdexamfetamine dimesylate
• Methamphetamine
• Methylphenidate
• tramadol
• isoniazid
• having conditions of probation or parole requiring reports of drug use to officers of the court
• personal history of epilepsy or seizure disorder and/or family history including a first-degree relative
• serious head injury with loss of consciousness
• impending incarceration
• pregnant or nursing for female patients
• inability to read, write, or speak English
• for adolescent aged participants (18-21 only): any risk factor for neurocardiogenic syncope (history of syncope/presyncope related to noxious stimuli, anxiety, micturition, or posture)
• hair style that is incompatible with EEG nets

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT05986578 · HSC-MS-21-0813 (Main study) · K01DA058765

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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