Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
28 mars 2022 mis à jour par: Shanghai Mental Health Center
Brain Mechanism and Intervention of Executive-control Dysfunction Caused by Impaired Prefrontal-ventral Striatum Synchronization Among Substance Dependents
The investigators assume that tACS could improve amphetamine and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway.
A random controlled trial will be used to test the effect of θ-tACS treatment.
Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
Substance abuse has become a major social and public health problem in China, especially for amphetamine abuse and alcohol abuse.
Executive-control dysfunction is the main symptom for substance dependents.
Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway.
Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognitive, and tACS could improve executive-control function by adjusting the abnormal synchronization.
But it has not been verified among MA or alcohol patients.
The investigators assume that tACS could improve MA and alcohol dependent patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway.
A random controlled trial will be used to test the effect of θ-tACS treatment.
Three months follow-up assessment will be conducted to test the changing of executive-control function and its mechanism.
This study will provide a practical and theoretical basis for developing a novel treatment for substance dependents.
Type d'étude
Interventionnel
Inscription (Anticipé)
210
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Jiang Du
- Numéro de téléphone: 021-64906315
- E-mail: dujiangdou@163.com
Lieux d'étude
-
-
Shanghai
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Shanghai, Shanghai, Chine, 200000
- Shanghai Mental Health Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 60 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests
- Meet DSM-5 diagnostic criteria for amphetamine-type substance addiction or alcohol addiction
- Have used amphetamine or alcohol for at least one year (at least once a week)
- Normal vision and hearing, or within the normal range after correction
- Agree to cooperate in the follow-up evaluation
- No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity
Exclusion Criteria:
- Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.
- Have used drugs promoting cognitive function in the last 6 months
- Have impaired intelligence (IQ<70)
- Abuse or dependence of other psychoactive substances (except nicotine) in the last 5 years
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Healthy control group
No intervention is conducted in the healthy control group.
|
|
|
Expérimental: Intervention group of amphetamine addiction
A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of amphetamine addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state.
Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value.
The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared.
The current value at this time was used as the stimulation current of the subjects.
|
|
Comparateur factice: Control group of amphetamine addiction
A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of amphetamine addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.
|
|
Expérimental: Intervention group of alcohol addiction
A 20-minute tACS intervention of real-stimulus is conducted twice a day for a total of 10 days in the intervention group of alcohol addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
Before the intervention, the individual alpha frequency (IAF) of the subjects was measured according to the average peak value of α waves at dorsolateral prefrontal cortex in the closed state.
Then an alternating current at θ frequency (θ = IAF - 5Hz) was applied to each subject based on its IAF value.
The amplitude of stimulation was increased with a step of 20μA starting from 0. When the subjects had a slight prickling sensation or optical illusion, the stimulation current was decreased with a step of 20μA until the sensation disappeared.
The current value at this time was used as the stimulation current of the subjects.
|
|
Comparateur factice: Control group of alcohol addiction
A 20-minute tACS intervention of sham-stimulus is conducted twice a day for a total of 10 days in the control group of alcohol addiction.
|
The adhesive electrodes were placed at F3 and F4 positions of the 64-bit EEG caps of the 10-20 system, corresponding to bilateral prefrontal lobes respectively.
The actual stimulation waveform was just implemented in the first 60 s (or more longer) and then faded out.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The change of inhibitory control ability
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
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The change of theta(θ) phase synchronicity
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
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The change of theta-gamma phase amplitude coupling(θ-γ PAC)
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The change of working memory
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of working memory will be measured by the two-back task.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
|
DA metabolic rate
Délai: baseline
|
DA metabolism was measured by Positron Emission Computed Tomography
|
baseline
|
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The change of decision-making ability
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of decision-making ability will be measured by the Balloon Analog Risk Task.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The The change of depression
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Depression will be measured by the Patient Health Questionnaire-9(PHQ-9).
The total score of PHQ-9 ranged from 0 to 27, in which higher scores mean a higher level of depression.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
|
The change of anxiety
Délai: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Anxiety will be measured by the questionnaire of Generalized Anxiety Disorder(GAD-7).
The total score of GAD-7 ranged from 0 to 21, in which higher scores mean a higher level of anxiety.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Anticipé)
1 juin 2022
Achèvement primaire (Anticipé)
1 juin 2025
Achèvement de l'étude (Anticipé)
31 décembre 2025
Dates d'inscription aux études
Première soumission
5 mars 2022
Première soumission répondant aux critères de contrôle qualité
28 mars 2022
Première publication (Réel)
5 avril 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
5 avril 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 mars 2022
Dernière vérification
1 janvier 2022
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JDu-010
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .