NCT06547996

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

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
completed

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 3, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

August 3, 2024

Last Update Submit

November 14, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The correct recall rate of word lists

    The correct recall rate of word lists was calculated for each subject by the experimental assistant.

    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.

    Immediate Test: 5minutes; Delayed Test: 24 hours

Study Arms (3)

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.

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.

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.

Device: tES-sham group

Interventions

2mA/20mins/session

tDCS group

2mA/40Hz/20mins/session

tACS group

0mA/20mins/session

sham group

Eligibility Criteria

Age18 Years - 60 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

Location

Related Publications (6)

  • 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.

    PMID: 27116682BACKGROUND
  • Sreeraj 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.

    PMID: 30024457BACKGROUND
  • Marko 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.

    PMID: 31776375BACKGROUND
  • Javadi 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.

    PMID: 23137702BACKGROUND
  • Crossman 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.

    PMID: 31550617BACKGROUND
  • McKay 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.

    PMID: 9162204BACKGROUND

Study Officials

  • Xiaofeng Ma, Professor

    Northwest Normal University

    PRINCIPAL INVESTIGATOR

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2024

First Posted

August 12, 2024

Study Start

August 30, 2024

Primary Completion

September 30, 2024

Study Completion

October 30, 2024

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations