- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06562504
Temporal Memory in Schizophrenic Patients
Transcranial Electrical Stimulation Combined With Interim Testing Promotes Temporal Memory in Patients With Schizophrenia
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tiantian Li, Doctor
- Phone Number: 13909483531
- Email: psylitiantian@outlook.com
Study Locations
-
-
Gansu
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Lanzhou, Gansu, China, 730070
- Recruiting
- Northwest Normal University
-
Contact:
- Xiaofeng Ma, Professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Anodal group
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.
|
2mA/20mins/session;
|
|
Sham Comparator: Sham group
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.
|
0mA/20mins/session
|
|
Experimental: tACS group
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.
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1.5 mA/20 min/session; 6HZ, theta
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correctness of temporal recall
Time Frame: 5mins to 24 hours
|
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
Time Frame: 5mins to 24 hours
|
The rate of intrusion of prior information when participants recalled the current information was counted.
|
5mins to 24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaofeng Ma, Professor, Northwest Normal University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- No.2024018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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