Schizophrenic PatientsNCT06547996
Effects of tES Combined With Retrieval Practice on Semantic Memory in Patients With Schizophrenia
A study testing tES-tDCS group and tES-tACS group in people with Schizophrenic Patients, run by Northeast Normal University at 1 site in China.
Trial summary
The semantic processing deficit stands as a central feature of cognitive abnormalities in schizophrenia. Both transcranial electrical stimulation (tES) and retrieval practice have been demonstrated as external techniques capable of ameliorating the semantic processing deficit in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenic Patients
- What is being tested?
- tES-tDCS group and tES-tACS group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 30 Oct 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 60 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.
About this study
Official title: Effects of Transcranial Electrical Stimulation Combined With Retrieval Practice on Semantic Memory in Patients With Schizophrenia
The semantic processing deficit stands as a central feature of cognitive abnormalities in schizophrenia. Both transcranial electrical stimulation (tES) and retrieval practice have been demonstrated as external techniques capable of ameliorating the semantic processing deficit in individuals with schizophrenia. The inquiry examines whether the combined effect of tES and retrieval practice, following tES intervention targeting the left dorsolateral prefrontal cortex (L-DLPFC) in patients with schizophrenia, contributes to the preservation of semantic memory in these individuals.
Investigators plan to recruit 60 patients diagnosed with schizophrenia from hospitals. Treatment is administered by two examiners, each patient receives transcranial electrical stimulation（2mA×20min） with simultaneous learning of word lists. Each participant of each stimulation type was involved in both learning conditions, meaning that all participants completed both retrieval and restudy learning and testing Subsequently, Investigators observed their immediate and delayed memory performance through tests.
Read the detailed description
- Stimulation phase: In the tDCS 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. In the tACS group, the anode was placed in the F3 region of the left dorsolateral prefrontal cortex (DLPFC), and the cathode was placed in the right supraorbital region (Fp2), and the current used was 2 mA AC at 40 Hz, with a stimulation time of 20 min. 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.
- Learning phase: The experimental procedure followed the classic retrieval practice paradigm, which included a learning phase and a final test phase. During the experiment, participants were informed that they would learn two lists of words. Subsequently, they might either learn the words again or complete a list recall test, and will be given a final test shortly thereafter. The learning of the retrieval practice list and the restudy list was conducted in a randomly balanced manner. Each word was presented for 5 seconds, with a 500-millisecond interval between words. To avoid providing secondary retrieval cues between examples, all words were shuffled pseudo-randomly within categories. Each list contained 17 words, consisting of 5 examples from each of the 3 experimental categories (15 experimental examples, 2 filler examples). The first and last words presented in each list were filler words, thus controlling for the primacy and recency effects on memory. For the retrieval practice list, participants underwent two learning sessions and two retrieval sessions (S-T-S-T). During retrieval, participants were instructed to write down all the words they had just remembered within 5 minutes. For the restudy list, participants underwent four study sessions (S-S-S-S). Between each learning cycle, participants completed a 3-minute simple arithmetic task (dispersed attention task).
- Testing phase:
Immediate Test: Participants were instructed to recall as many words as possible from the learned lists within 10 minutes after completing all learning tasks.
Delayed Test: Participants were informed to recall as many words as possible from the learned lists within 10 minutes 24 hours later.
- Conditions
- Schizophrenic Patients
- Being tested
- tES-tDCS group, tES-tACS group, tES-sham group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tES-tDCS groupDevice
2mA/20mins/session
tES-tACS groupDevice
2mA/40Hz/20mins/session
tES-sham groupDevice
0mA/20mins/session
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | In the tDCS 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: tES-tDCS group |
| tACS group | Experimental | In the tACS group, the anode was placed in the F3 region of the left dorsolateral prefrontal cortex (DLPFC), and the cathode was placed in the right supraorbital region (Fp2), and the current used was 2 mA AC at 40 Hz, with a stimulation time of 20 min. Receives: Device: tES-tACS 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: tES-sham group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correct recall rate of word lists
The correct recall rate of word lists was calculated for each subject by the experimental assistant.
Measured: Immediate Test: 5minutes; Delayed Test: 24 hours
Adjusted Ratio of Clustering (ARC)
Free recall organization was measured by the Adjusted Ratio of Clustering (ARC) scores. ARC scores range from 1 to 1. A 0 score indicates a level of clustering similar to what would be expected by chance, and a score of 1 implies perfect clustering. Negative values of ARC scores mean atypical and uninterpretable recall patterns. For that reason, negative scores were excluded from analyses.
Measured: Immediate Test: 5minutes; Delayed Test: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start30 Aug 2024
- Primary completion30 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Schizophrenic PatientsStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaofeng Ma, Northeast Normal University
- Investigators
- Xiaofeng Ma, Professor, Principal investigator, Northwest Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547996
- Sponsor's protocol ID
- No.2023025
- Status last verified
- Nov 2024
- First submitted
- 3 Aug 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoy KE, Whitty D, Bailey N, Fitzgerald PB. Preliminary investigation of the effects of gamma-tACS on working memory in schizophrenia. J Neural Transm (Vienna). 2016 Oct;123(10):1205-12. doi: 10.1007/s00702-016-1554-1. Epub 2016 Apr 26.
PubMed 27116682Sreeraj VS, Shivakumar V, Sowmya S, Bose A, Nawani H, Narayanaswamy JC, Venkatasubramanian G. Online Theta Frequency Transcranial Alternating Current Stimulation for Cognitive Remediation in Schizophrenia: A Case Report and Review of Literature. J ECT. 2019 Jun;35(2):139-143. doi: 10.1097/YCT.0000000000000523.
PubMed 30024457Marko M, Cimrova B, Riecansky I. Neural theta oscillations support semantic memory retrieval. Sci Rep. 2019 Nov 27;9(1):17667. doi: 10.1038/s41598-019-53813-y.
PubMed 31776375Javadi AH, Cheng P. Transcranial direct current stimulation (tDCS) enhances reconsolidation of long-term memory. Brain Stimul. 2013 Jul;6(4):668-74. doi: 10.1016/j.brs.2012.10.007. Epub 2012 Oct 31.
PubMed 23137702Crossman M, Bartl G, Soerum R, Sandrini M. Effects of transcranial direct current stimulation over the posterior parietal cortex on episodic memory reconsolidation. Cortex. 2019 Dec;121:78-88. doi: 10.1016/j.cortex.2019.08.009. Epub 2019 Aug 28.
PubMed 31550617McKay AP, McKenna PJ, Bentham P, Mortimer AM, Holbery A, Hodges JR. Semantic memory is impaired in schizophrenia. Biol Psychiatry. 1996 Jun 1;39(11):929-37. doi: 10.1016/0006-3223(95)00250-2.
PubMed 9162204
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Electrical Stimulation Combined With Retrieval Practice on Semantic Memory in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT06547996
- Acronym / sponsor ID
- No.2023025
- Conditions
- Schizophrenic Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 12 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.
The semantic processing deficit stands as a central feature of cognitive abnormalities in schizophrenia. Both transcranial electrical stimulation (tES) and retrieval practice have been demonstrated as external techniques capable of ameliorating the semantic processing deficit in individuals with schizophrenia. The inquiry examines whether the combined effect of tES and retrieval practice, following tES intervention targeting the left dorsolateral prefrontal cortex (L-DLPFC) in patients with schizophrenia, contributes to the preservation of semantic memory in these individuals.
Investigators plan to recruit 60 patients diagnosed with schizophrenia from hospitals. Treatment is administered by two examiners, each patient receives transcranial electrical stimulation（2mA×20min） with simultaneous learning of word lists. Each participant of each stimulation type was involved in both learning conditions, meaning that all participants completed both retrieval and restudy learning and testing Subsequently, Investigators observed their immediate and delayed memory performance through tests.
Detailed description
- Stimulation phase: In the tDCS 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. In the tACS group, the anode was placed in the F3 region of the left dorsolateral prefrontal cortex (DLPFC), and the cathode was placed in the right supraorbital region (Fp2), and the current used was 2 mA AC at 40 Hz, with a stimulation time of 20 min. 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.
- Learning phase: The experimental procedure followed the classic retrieval practice paradigm, which included a learning phase and a final test phase. During the experiment, participants were informed that they would learn two lists of words. Subsequently, they might either learn the words again or complete a list recall test, and will be given a final test shortly thereafter. The learning of the retrieval practice list and the restudy list was conducted in a randomly balanced manner. Each word was presented for 5 seconds, with a 500-millisecond interval between words. To avoid providing secondary retrieval cues between examples, all words were shuffled pseudo-randomly within categories. Each list contained 17 words, consisting of 5 examples from each of the 3 experimental categories (15 experimental examples, 2 filler examples). The first and last words presented in each list were filler words, thus controlling for the primacy and recency effects on memory. For the retrieval practice list, participants underwent two learning sessions and two retrieval sessions (S-T-S-T). During retrieval, participants were instructed to write down all the words they had just remembered within 5 minutes. For the restudy list, participants underwent four study sessions (S-S-S-S). Between each learning cycle, participants completed a 3-minute simple arithmetic task (dispersed attention task).
- Testing phase:
Immediate Test: Participants were instructed to recall as many words as possible from the learned lists within 10 minutes after completing all learning tasks.
Delayed Test: Participants were informed to recall as many words as possible from the learned lists within 10 minutes 24 hours later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Device: tES-tDCS groupIn the tDCS 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. |
| tACS group | Experimental | Device: tES-tACS groupIn the tACS group, the anode was placed in the F3 region of the left dorsolateral prefrontal cortex (DLPFC), and the cathode was placed in the right supraorbital region (Fp2), and the current used was 2 mA AC at 40 Hz, with a stimulation time of 20 min. |
| sham group | Sham comparator | Device: tES-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. |
Who may qualify
- Ages
- 18 to 60 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 |
|---|---|---|
| tES-tDCS group2mA/20mins/session | Device | tDCS group |
| tES-tACS group2mA/40Hz/20mins/session | Device | tACS group |
| tES-sham group0mA/20mins/session | Device | sham group |
Primary outcome
The correct recall rate of word lists
Time frame: Immediate Test: 5minutes; Delayed Test: 24 hours
The correct recall rate of word lists was calculated for each subject by the experimental assistant.
Adjusted Ratio of Clustering (ARC)
Time frame: Immediate Test: 5minutes; Delayed Test: 24 hours
Free recall organization was measured by the Adjusted Ratio of Clustering (ARC) scores. ARC scores range from 1 to 1. A 0 score indicates a level of clustering similar to what would be expected by chance, and a score of 1 implies perfect clustering. Negative values of ARC scores mean atypical and uninterpretable recall patterns. For that reason, negative scores were excluded from analyses.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 27116682Hoy KE, Whitty D, Bailey N, Fitzgerald PB. Preliminary investigation of the effects of gamma-tACS on working memory in schizophrenia. J Neural Transm (Vienna). 2016 Oct;123(10):1205-12. doi: 10.1007/s00702-016-1554-1. Epub 2016 Apr 26.
- Background: PubMed 30024457Sreeraj VS, Shivakumar V, Sowmya S, Bose A, Nawani H, Narayanaswamy JC, Venkatasubramanian G. Online Theta Frequency Transcranial Alternating Current Stimulation for Cognitive Remediation in Schizophrenia: A Case Report and Review of Literature. J ECT. 2019 Jun;35(2):139-143. doi: 10.1097/YCT.0000000000000523.
- Background: PubMed 31776375Marko M, Cimrova B, Riecansky I. Neural theta oscillations support semantic memory retrieval. Sci Rep. 2019 Nov 27;9(1):17667. doi: 10.1038/s41598-019-53813-y.
- Background: PubMed 23137702Javadi AH, Cheng P. Transcranial direct current stimulation (tDCS) enhances reconsolidation of long-term memory. Brain Stimul. 2013 Jul;6(4):668-74. doi: 10.1016/j.brs.2012.10.007. Epub 2012 Oct 31.
- Background: PubMed 31550617Crossman M, Bartl G, Soerum R, Sandrini M. Effects of transcranial direct current stimulation over the posterior parietal cortex on episodic memory reconsolidation. Cortex. 2019 Dec;121:78-88. doi: 10.1016/j.cortex.2019.08.009. Epub 2019 Aug 28.
- Background: PubMed 9162204McKay AP, McKenna PJ, Bentham P, Mortimer AM, Holbery A, Hodges JR. Semantic memory is impaired in schizophrenia. Biol Psychiatry. 1996 Jun 1;39(11):929-37. doi: 10.1016/0006-3223(95)00250-2.
- 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 tES-tDCS group and tES-tACS group in people with Schizophrenic Patients, run by Northeast Normal University 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: finished, as of the sponsor's last update on 15 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correct recall rate of word lists (time frame: Immediate Test: 5minutes; Delayed Test: 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?
On the ClinicalTrials.gov record for NCT06547996, which also lists 6 linked publications.
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 15 Nov 2024.