Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
28 marca 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Warunki
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
210
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Jiang Du
- Numer telefonu: 021-64906315
- E-mail: dujiangdou@163.com
Lokalizacje studiów
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Shanghai
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Shanghai, Shanghai, Chiny, 200000
- Shanghai Mental Health Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 60 lat (Dorosły)
Akceptuje zdrowych ochotników
Tak
Płeć kwalifikująca się do nauki
Wszystko
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Healthy control group
No intervention is conducted in the healthy control group.
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Eksperymentalny: 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.
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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.
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Pozorny komparator: 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.
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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.
|
|
Eksperymentalny: 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.
|
|
Pozorny komparator: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The change of inhibitory control ability
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of inhibitory control ability will be reflected by participants' performance in the Go/No Go task.
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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
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of θ phase synchronicity in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
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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)
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of θ-γ PAC in the prefrontal - ventral striatum pathway in amphetamine addicts and alcohol addicts will be measured by EEG.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The change of working memory
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of working memory will be measured by the two-back task.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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DA metabolic rate
Ramy czasowe: baseline
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DA metabolism was measured by Positron Emission Computed Tomography
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baseline
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The change of decision-making ability
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of decision-making ability will be measured by the Balloon Analog Risk Task.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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The The change of depression
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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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.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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The change of anxiety
Ramy czasowe: baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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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.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
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Współpracownicy i badacze
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
1 czerwca 2022
Zakończenie podstawowe (Oczekiwany)
1 czerwca 2025
Ukończenie studiów (Oczekiwany)
31 grudnia 2025
Daty rejestracji na studia
Pierwszy przesłany
5 marca 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
28 marca 2022
Pierwszy wysłany (Rzeczywisty)
5 kwietnia 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 kwietnia 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
28 marca 2022
Ostatnia weryfikacja
1 stycznia 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- JDu-010
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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