Neuromodulation of Executive Control for Substance Use Disorders
TACS fMRI (NEC-TACS)
The purpose of this research study is to determine the effectiveness of a procedure called transcranial alternating current stimulation (tACS) using a device called StarStim cap and its effects on drug cravings.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Participants will undergo a 1-2-day screening that includes a urine drug screen, clinical interview, and self-reporting assessments, once screening is complete, participants will complete a (EEG) recording of your brainwaves. The EEG recording and electrode placement will take about 2 hours. The next portion of the study will involve the use of the StarStim device and an MRI, and you will be asked a series of questions while wearing the device. The day after the MRI scan you will receive a short phone call from study staff. You will be asked to participate in study visits for 2 or 3 days and have 1 follow-up visit. Total study duration for this research study is up to 2 weeks.
The electrical stimulation that the StarStim device uses is considered to be safe, and we are not anticipating any serious side effects. However, mild side effects could include headache, itching and tingling. There are additional risks involved with MRI scans.
You may not receive any personal benefits from being in this study. We hope the information learned from this study will benefit other people with similar conditions in the future.
If you are interested in learning more about this study, please continue to read below. Participating in this research study is voluntary; it is your choice.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Aref Pariz, PhD
- Numéro de téléphone: 612-624-0134
- E-mail: Aref.Pariz@UTSouthwestern.edu
Sauvegarde des contacts de l'étude
- Nom: Stephanie Neaves, MRC
- Numéro de téléphone: 214-648-86044
Lieux d'étude
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Texas
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Dallas, Texas, États-Unis, 75235
- UT Southwestern Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Able to provide written consent and comply with study procedures.
- Adults aged 18 to 65 years at the time of consent.
- Meets the MINI diagnostic criteria for either methamphetamine use disorder (MUD).
Exclusion Criteria:
- Any contraindications for tACS or MRI scanning (tACS contraindication: history of seizures; potential MRI contraindications, up to the discretion of AIRC and CBH staff: metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder).
- Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor).
- Over 9 months of abstinence from substance use.
- A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI).
- Presence of a condition that would render study measures difficult or impossible to administer or interpret.
- Entrance to the treatment program under a court mandate. (i.e. legally incarcerated).
- History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm 1: Active intervention- tES (transcranial electrical stimulation), then Sham Intervention
tES is considered to be a safe brain stimulation technique that rarely results in adverse events. There is currently no evidence of serious side-effects. Mild side-effects that typically resolve upon discontinuing tACS. The subject may choose to discontinue stimulation at any time during the session if experiencing excessive discomfort or side effects. |
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
|
Expérimental: Arm 2: Sham intervention, then Active comparator intervention
|
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Brain stimulation and MRI
Délai: Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
Task-dependent functional connectivity measured using psychophysiological interaction (PPI) analysis of blood oxygen level-dependent (BOLD) functional MRI data. PPI regression coefficients quantify differences in connectivity during drug-related versus neutral cues within the executive control network, including the dorsolateral prefrontal cortex and inferior parietal cortex, and between executive control regions and limbic regions, including the ventral striatum and amygdala. Connection-specific PPI coefficients will be reported separately, with within-participant comparisons between active in-phase, active anti-phase, and sham tACS conditions. |
Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STU20252588
Informations sur les médicaments et les dispositifs, documents d'étude
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