Brain Mechanism and Intervention of Executive-control Dysfunction Among Substance Dependents
28. mars 2022 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
210
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Jiang Du
- Telefonnummer: 021-64906315
- E-post: 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Healthy control group
No intervention is conducted in the healthy control group.
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|
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Eksperimentell: 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.
|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
baseline, immediately after the intervention, one month after the intervention, three months after the intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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
Tidsramme: baseline
|
DA metabolism was measured by Positron Emission Computed Tomography
|
baseline
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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 |
Tiltaksbeskrivelse |
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
|
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The change of anxiety
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. juni 2022
Primær fullføring (Forventet)
1. juni 2025
Studiet fullført (Forventet)
31. desember 2025
Datoer for studieregistrering
Først innsendt
5. mars 2022
Først innsendt som oppfylte QC-kriteriene
28. mars 2022
Først lagt ut (Faktiske)
5. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. april 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. mars 2022
Sist bekreftet
1. januar 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JDu-010
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Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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