NCT06562504

Brief Summary

Temporal order memory deficits are a central feature of cognitive abnormalities in schizophrenia. The dorsolateral prefrontal cortex contributes to the extraction of temporal contextual information. Transcranial direct current stimulation (tDCS) and interim testing have been shown to be external techniques that can improve temporal order memory deficits in schizophrenia patients. Transcranial alternating current stimulation (tACS) can also improve cognitive functioning in patients with schizophrenia. This study intends to investigate the learning effects of temporal order memory under two learning strategies during tDCS targeting the left dorsolateral prefrontal cortex (L-DLPFC) and transcranial direct current stimulation (tDCS) interventions in patients with schizophrenia, to investigate whether it can promote the retention of temporal order memory in patients, and to compare the differences in the effects of the two intervention modalities. This study was planned to recruit 75 patients diagnosed with schizophrenia from the hospital. A single online tDCS (2 mA × 20 min) and tACS (1.5 mA × 20 min, theta rhythm) intervention was conducted during which participants performed a temporal-sequence memory task for visual pictures, and test scores were compared for each stimulus type on an intermediate test and repetition of the two strategies of learning.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 15, 2024

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Correctness of temporal recall

    Stimulus content was presented using the Eprime experimental program, and participants pressed key responses during the test phase to record their rate of correctness. Stimulus content was presented using the Eprime experimental program, and participants pressed key responses during the test phase to record their rate of correctness.

    5mins to 24 hours

  • proactive interference rate

    The rate of intrusion of prior information when participants recalled the current information was counted.

    5mins to 24 hours

Study Arms (3)

Anodal group

EXPERIMENTAL

In the anodal group, the anode was placed over the left DLPFC (F3), and the cathode was placed over the contralateral supraorbital area (FP2). A direct current of 2mA was applied for 20 minutes during each stimulation session.

Device: Transcranial direct current stimulation (tDCS)- anodal group

Sham group

SHAM COMPARATOR

In the sham group, the stimulation parameters, including the stimulation site and duration, were identical to those of the anodal group. However, during the 10-second ramp-up and ramp-down periods before and after stimulation, patients were unaware that the current was turned off.

Device: Transcranial direct current stimulation (tDCS)- sham group

tACS group

EXPERIMENTAL

In the transcranial alternating current stimulation (tACS) group, the anode was placed in the left DLPFC (F3) and the cathode was placed in the contralateral supraorbital region (FP2). A direct current of 1.5 mA was applied for 20 minutes during each stimulation, theta rhythm, 6 HZ.

Device: transcranial alternating current stimulation (tACS)-tACS group

Interventions

1.5 mA/20 min/session; 6HZ, theta

tACS group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meeting the diagnostic criteria for schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
  • Aged 18 years or older, regardless of gender, with an educational level of elementary school or above;
  • All patients received stable-level antipsychotic medication treatment, were in a stable phase of disease treatment, able to understand the testing requirements, and cooperated to complete all research tasks;
  • No history of neurological disorders or other serious physical illnesses, and no history of intellectual disability;
  • No color blindness, color weakness, or other color vision impairments, with normal vision or corrected vision.

You may not qualify if:

  • Clear cognitive impairment caused by somatic or cerebral organic lesions, such as cerebrovascular diseases, traumatic brain injury, etc;
  • Individuals with mental disorders caused by substance dependence or abuse, or the use of psychoactive substances;
  • History of brain injury or other central nervous system-related organic diseases;
  • Individuals at significant risk of suicide or harming others;
  • Participation in similar experiments in the past 30 days prior to baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwest Normal University

Lanzhou, Gansu, 730070, China

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Xiaofeng Ma, Professor

    Northwest Normal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiantian Li, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 20, 2024

Study Start

August 15, 2024

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations