Patients With SchizophreniaNCT06562504
Temporal Memory in Schizophrenic Patients
A study testing Transcranial direct current stimulation (tDCS)- anodal group and transcranial alternating current stimulation (tACS)-tACS group in people with Patients With Schizophrenia, run by Xiaofeng Ma at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patients With Schizophrenia
- What is being tested?
- Transcranial direct current stimulation (tDCS)- anodal group and transcranial alternating current stimulation (tACS)-tACS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Northwest Normal University
Lanzhou, Gansu, 730070
Xiaofeng Ma, Professor
About this study
Official title: 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.
Read the detailed description
Treatment was conducted by two examiners, and participants' memory levels were tested before the start of the experiment using a flanker task and a numerical breadth task as baseline tests. The experimental procedure was divided into a learning phase, in which participants memorized the sequence of pictures, and a testing phase, in which participants were required to recall a picture presented after the probe item. Participants were randomly assigned in parallel to each stimulus type and learning strategy, with 25 receiving tdcs anodized stimuli, 25 receiving sham stimuli, and another 25 receiving tacs stimuli. And participants' inhibitory control continued to be tested using the flanker task before and after the stimuli for pre- and post-intervention comparisons.
- Conditions
- Patients With Schizophrenia
- Being tested
- Transcranial direct current stimulation (tDCS)- anodal group, Transcranial direct current stimulation (tDCS)- sham group, transcranial alternating current stimulation (tACS)-tACS group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)- anodal groupDevice
2mA/20mins/session;
Transcranial direct current stimulation (tDCS)- sham groupDevice
0mA/20mins/session
transcranial alternating current stimulation (tACS)-tACS groupDevice
1.5 mA/20 min/session; 6HZ, theta
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: transcranial alternating current stimulation (tACS)-tACS group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5mins to 24 hours
proactive interference rate
The rate of intrusion of prior information when participants recalled the current information was counted.
Measured: 5mins to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start15 Aug 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaofeng Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaofeng Ma, Northeast Normal University
- Investigators
- Xiaofeng Ma, Professor, Principal investigator, Northwest Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562504
- Sponsor's protocol ID
- No.2024018
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Electrical Stimulation Combined With Interim Testing Promotes Temporal Memory in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06562504
- Acronym / sponsor ID
- No.2024018
- Conditions
- Patients With Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Xiaofeng MaUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment was conducted by two examiners, and participants' memory levels were tested before the start of the experiment using a flanker task and a numerical breadth task as baseline tests. The experimental procedure was divided into a learning phase, in which participants memorized the sequence of pictures, and a testing phase, in which participants were required to recall a picture presented after the probe item. Participants were randomly assigned in parallel to each stimulus type and learning strategy, with 25 receiving tdcs anodized stimuli, 25 receiving sham stimuli, and another 25 receiving tacs stimuli. And participants' inhibitory control continued to be tested using the flanker task before and after the stimuli for pre- and post-intervention comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal group | Experimental | Device: Transcranial direct current stimulation (tDCS)- anodal groupIn 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. |
| Sham group | Sham comparator | Device: Transcranial direct current stimulation (tDCS)- sham groupIn 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. |
| tACS group | Experimental | Device: transcranial alternating current stimulation (tACS)-tACS groupIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (tDCS)- anodal group2mA/20mins/session; | Device | Anodal group |
| Transcranial direct current stimulation (tDCS)- sham group0mA/20mins/session | Device | Sham group |
| transcranial alternating current stimulation (tACS)-tACS group1.5 mA/20 min/session; 6HZ, theta | Device | tACS group |
Primary outcome
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.
proactive interference rate
Time frame: 5mins to 24 hours
The rate of intrusion of prior information when participants recalled the current information was counted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Ma, Professor principal investigator
Northwest Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS)- anodal group and transcranial alternating current stimulation (tACS)-tACS group in people with Patients With Schizophrenia, run by Xiaofeng Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiantian Li, Doctor (13909483531, psylitiantian@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctness of temporal recall (time frame: 5mins to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.