- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05312359
Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
28. marts 2022 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
210
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jiang Du
- Telefonnummer: 021-64906315
- E-mail: dujiangdou@163.com
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200000
- Shanghai Mental Health Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Healthy control group
No intervention is conducted in the healthy control group.
|
|
Eksperimentel: 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.
|
Sham-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.
|
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.
|
Eksperimentel: 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.
|
Sham-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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The change of inhibitory control ability
Tidsramme: 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
|
The change of theta(θ) phase synchronicity
Tidsramme: 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
|
The change of theta-gamma phase amplitude coupling(θ-γ PAC)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The change of working memory
Tidsramme: 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
Tidsramme: baseline
|
DA metabolism was measured by Positron Emission Computed Tomography
|
baseline
|
The change of decision-making ability
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The The change of depression
Tidsramme: 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.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
The change of anxiety
Tidsramme: 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.
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baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Forventet)
1. juni 2022
Primær færdiggørelse (Forventet)
1. juni 2025
Studieafslutning (Forventet)
31. december 2025
Datoer for studieregistrering
Først indsendt
5. marts 2022
Først indsendt, der opfyldte QC-kriterier
28. marts 2022
Først opslået (Faktiske)
5. april 2022
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. april 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. marts 2022
Sidst verificeret
1. januar 2022
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JDu-010
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