Online HD-tDCS Over the Left DLPFC During a Working Memory Task for Treating Negative Symptoms of Schizophrenia

NCT05582980 | Completed

• 1 other identifier: 1-108-03-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized double-blind trial, the investigators aim to investigate whether online high definition transcranial direct current stimulation (HD-tDCS) over the left dorsolateral prefrontal cortex (DLPFC) during a working memory task improves the severity of negative symptoms in schizophrenia patients with predominant negative symptoms.

Conditions

Schizophrenia; Schizoaffective Disorder, Mixed Type; Negative Symptoms in Schizophrenia

Keywords

Schizophrenia; Negative Symptoms; Dorsolateral prefrontal cortex; HD-tDCS; Working memory tasks

Outcome Measures

Primary Outcomes (1)

• The change over time in the Chinese version of the Positive and Negative Syndrome Scale Factor Score for Negative Symptoms (PANSS-FSNS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  PANSS is a clinician-administered rating scale to measure the severity of psychopathological symptoms of the patients with schizophrenia spectrum disorder. The patient is rated from 1 to 7 on 30 different symptom items. All items scores are summed up to yield a total PANSS score, which ranges from 30 to 210. A higher score indicates greater psychopathological symptom severity. The five-factor PANSS model can be obtained by calculating from 26 of 30 items of PANSS to represent positive, negative, grandiosity/excitement, disorganization, and depression factor scores, respectively. In this model, PANSS-FSNS (7 items, N1+N2+N3+N4+N6+G7+G16, score 7-49) is selected as the primary outcome.

  Five weeks

Secondary Outcomes (21)

• The change over time in the score of the Chinese version of the Scale for the Assessment of Negative Symptoms (SANS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  Five weeks

• The change over time in the scores of two subdomains of PANSS negative symptoms (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  Five weeks

• The change over time in the scores of the five-factor PANSS model other than FSNS (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  Five weeks

• The change over time in the score of the Chinese version of the Personal and Social Performance scale (PSP) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  Five weeks

• The change over time in the score of the self-reported version of the graphic personal and social performance scale (SRG-PSP) (from baseline to the timepoints immediately after intervention and at one-week follow-up)

  Two weeks

Study Arms (2)

HD-tDCS (active)

EXPERIMENTAL

Stimulation will be applied by a battery-operated device (NeuroConn DC Stimulator Plus) via 5 carbon rubber electrodes (1 cm radius, high-definition 4 × 1 rings configuration). To target the left DLPFC, the central electrode (anode) will be placed over International 10-20 electrode position F3, with return peripheral electrodes at Fp1, Fz, C3 and F7. Stimulation will be applied at an intensity of 2 milliamp (mA), 8-sec fade in and 5-sec fade out, for 20 min, two times daily, on 5 consecutive weekdays (total 10 sessions). During each session, the subject has to perform a computerized working memory task (i.e., 2-back task). The two times daily sessions will be separated by at least 2 hours.

Device: HD-tDCS

HD-tDCS (sham)

SHAM COMPARATOR

In sham stimulation, the electrode montage and protocol will be the same as the active stimulation, except the 2 mA current will be turned on for 30 sec and then ramped down to 0 mA through the remainder of the 20-min time.

Device: HD-tDCS

Interventions

HD-tDCS DEVICE

See detail in arm/group descriptions regarding the intervention.

HD-tDCS (active); HD-tDCS (sham)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 20-65 years and diagnosed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ( DSM-5 ) schizophrenia or schizoaffective disorder
• Duration of illness≧1 year
• With a clinical presentation of predominant negative symptoms (according to the clinical judgment of 2 experienced psychiatrists) and the Positive and Negative Syndrome Scale (PANSS) score \> 70
• Receiving stable antipsychotic drug regimen \>8 weeks.

You may not qualify if:

• Subjects with current psychiatric comorbidity or active substance use disorder with the exception of caffeine and/or tobacco
• Having contraindications for tDCS, e.g., implanted brain medical devices or metal in the head
• Pregnancy at enrollment
• Having a history of seizures, intracranial neoplasms or surgery, severe head injuries, or cerebrovascular diseases

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• Ma CC, Lin YY, Chung YA, Park SY, Huang CC, Chang WC, Chang HA. The two-back task leads to activity in the left dorsolateral prefrontal cortex in schizophrenia patients with predominant negative symptoms: a fNIRS study and its implication for tDCS. Exp Brain Res. 2024 Mar;242(3):585-597. doi: 10.1007/s00221-023-06769-5. Epub 2024 Jan 16.

  PMID: 38227007 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hsin-An Chang, M.D.

  Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation concealment was further ensured by the administration of HD-tDCS using "study mode of the device" in which a five-digit numerical code specific to individual participant was entered into the device (Eldith DC stimulator Plus, NeuroConn, Ilmenau, Germany) that resulted in either active or sham stimulation, i.e., the researcher got the randomization code and a unique five-digit numerical code for an individual participant from the study coordinator while HD-tDCS administrator entered the code for study mode into the device. The study coordinator had continuous access to the randomization list and unblinded the study after the final visit of the last participant. Not until the unblinding of the trial did the participants, HD-tDCS administrators, researchers and clinical raters know the actual stimulation types.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Attending Psychiatrist, Department of Psychiatry

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 17, 2022
• Study Start: June 15, 2020
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)