Theta tACS During Working Memory Training: A Pilot Study of the Effects on Negative Symptoms of Schizophrenia

NCT04545294 | Completed

• 1 other identifier: 2-106-05-123
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized double-blind trial, we investigated whether externally induced left-hemispheric frontoparietal theta synchronization by multi-electrode online theta (6Hz) transcranial alternating current stimulation (tACS) would enhance the influence of a working memory training on negative symptoms of schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder; Negative Symptoms; Working Memory Training; Psychosocial Impairment; Autonomic Imbalance; EEG

Keywords

Schizophrenia; Schizoaffective Disorder; Transcranial alternating current stimulation; Theta oscillatory rhythm; Theta Phase-Coupling; Negative symptoms; Working memory training

Outcome Measures

Primary Outcomes (1)

• The change over time in the negative symptoms subscale score of the Chinese version of the Positive and Negative Syndrome Scale (PANSS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  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. There are 7 items for positive symptoms subscale (score 7-49), 7 items for negative symptoms subscale (score 7-49), 16 items for general symptoms subscale (score 16-112).

  Five weeks

Secondary Outcomes (18)

• 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).

  Five weeks

• 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 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

• The change over time in the score of the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia (SUMD) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups).

  Five weeks

Study Arms (2)

Active theta (6Hz) in-phase tACS

EXPERIMENTAL

θ tACS will be administered during the dual n-back task, starting at the beginning of each task and lasting for 20 min. In the active θ tACS condition, sinusoidal tACS will be delivered by two battery-operated devices (Eldith DC stimulator Plus, neuroConn, Ilmenau, Germany) connected with two 4 × 1 wire adaptors (Equalizer Box, NeuroConn, Ilmenau, Germany), via 10 carbon rubber electrodes (1 cm radius, high-definition 4 × 1 rings configuration with a gel layer of 2.0 mm), at 6 Hz frequency, 2 mA current intensity without DC offset, with 100 cycles ramp-up/ramp-down and a 0° relative phase, for 20 min, twice-daily on 5 consecutive weekdays.

Device: Theta tACS

Sham tACS

SHAM COMPARATOR

During sham sessions, tACS will be applied in the synchronous condition for 30 s of 2 mA normal-like stimulation at the beginning of each dual n-back task. After that, only a tiny current pulse (110 μA over 15 ms) for impedance control took place every 550 ms during the remaining time.

Device: Theta tACS

Interventions

Theta tACS DEVICE

See detail in arm/group descriptions regarding the intervention.

Active theta (6Hz) in-phase tACS; Sham tACS

Eligibility Criteria

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

You may qualify if:

• Eligible participants aged 20-65 with DSM-V-defined schizophrenia or schizoaffective disorder.
• Duration of illness \> 2 years.
• Being clinically stable and on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment.
• Agreement to participate in the study and provide the written informed consent.

You may not qualify if:

• Having unstable medical conditions, current psychiatric comorbidity or active substance use disorder (in exception to caffeine and/or tobacco).
• Having a history of seizures, meningitis or encephalitis.
• Having contraindications for transcranial electrical stimulation or transcranial magnetic stimulation, e.g., pacemakers, metallic or magnetic pieces in the head/brain, ear implants and other implantible brain medical devices.
• Having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
• Pregnancy or breastfeeding at enrollment.
• Skin lesions on scalp at the area of electrode application

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

Related Publications (23)

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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

  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 tACS 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 tACS 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, tACS administrators, researchers and clinical raters know the actual stimulation types.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist, Department of Psychiatry, Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 11, 2020
• Study Start: August 14, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Locations

TW (1)