The Effects of Bimodal tDCS on Illness Severity, Insight, Functional Outcomes, Neurocognition and HRV in Schizophrenia

NCT03701100 | Completed

• 1 other identifier: 2-103-03-002-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to investigate the effects of bimodal anodal transcranial direct current stimulation (tDCS) over bilateral dorsolateral prefrontal cortex (DLPFC) on psychopathological symptoms, insight, psychosocial functioning, neurocognitive function and heart rate variability (HRV) in schizophrenia patients

Conditions

Schizophrenia; Insight Impaired; Psychotic Symptoms; Schizoaffective Disorder; Neurocognitive Dysfunction; Autonomic Imbalance; Psychosocial Impairment; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Changes from baseline scores of Positive and Negative Syndrome Scale (PANSS) at the timepoint immediately after tDCS, at one month and three months after tDCS.

  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. Then, five main symptom dimension subscales of PANSS can be calculated from 26 of 30 items of PANSS: positive (5 items, score 5-35) , negative (8 items, score 8-56), grandiosity/excitement (4 items, score 4-28), disorganization (5 items, score 5-35), and depression (4 items, score 4-28).

  Three months

Secondary Outcomes (16)

• Changes from baseline scores at Personal and Social Performance scale (PSP) at the timepoint immediately after tDCS, at one month and three months after tDCS.

  Three months

• Changes from baseline scores of the Global Assessment of Functioning (GAF) Scale of the DSM-IV at the timepoint immediately after tDCS, at one month and three months after tDCS.

  Three months.

• Changes from baseline scores of the Clinical Global Impression (CGI) rating scales at the timepoint immediately after tDCS, at one month and three months after tDCS.

  Three months.

• Changes from baseline scores of the self-reported version of the graphic personal and social performance scale (SRG-PSP) at the timepoint immediately after tDCS and at one month after tDCS.

  One month.

• Changes from baseline scores of the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia (SUMD) at the timepoint immediately after tDCS, at one month and three months after tDCS.

  Three months.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Direct current (DC) generated by a Eldith DC stimulator was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 square centimeter). One anode was placed with the middle of the electrode over a point midway between International 10-20 electrode positions F3 and Fp1 (left dorsolateral prefrontal cortex and left prefrontal cortex). The other was located over a point midway between F4 and Fp2 (right dorsolateral prefrontal cortex and left prefrontal cortex). The reference electrodes were placed on bilateral forearms. Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. All patients in the active tDCS group were maintained on their antipsychotic medications throughout the study period.

Device: tDCS

Sham tDCS

SHAM COMPARATOR

In sham stimulation, the current was turned on for 30 sec and then ramped down to 0 mA. All patients in the sham tDCS group were maintained on their antipsychotic medications throughout the study period.

Device: tDCS

Interventions

tDCS DEVICE

tDCS

Active tDCS; Sham tDCS

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-IV-TR-defined schizophrenia or schizoaffective disorder.
• Duration of illness ≧ 1 year.
• Being on an adequate therapeutic dose of antipsychotics and clinically stable (nonacute phase of illness) but symptomatic for at least 4 weeks prior to enrolment as defined by Clinical Global Impression-Severity of Illness scale (CGI-S) score ≦ 4 (at both screening and baseline).
• Agreement to participate in the study and provide the written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• Chang CC, Kao YC, Chao CY, Tzeng NS, Chang HA. Examining bi-anodal transcranial direct current stimulation (tDCS) over bilateral dorsolateral prefrontal cortex coupled with bilateral extracephalic references as a treatment for negative symptoms in non-acute schizophrenia patients: A randomized, double-blind, sham-controlled trial. Prog Neuropsychopharmacol Biol Psychiatry. 2020 Jan 10;96:109715. doi: 10.1016/j.pnpbp.2019.109715. Epub 2019 Jul 27.

  PMID: 31362034 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hsin-An Chang, M.D.

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In sham stimulation, the current was turned on for 30 sec and then ramped down to 0 mA.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Psychiatrist, Department of Psychiatry, Principal Investigator, Assistant Professor

Model Details: Direct current (DC) generated by a Eldith DC stimulator was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 square centimeter). One anode was placed with the middle of the electrode over a point midway between International 10-20 electrode positions F3 and Fp1 (left dorsolateral prefrontal cortex and left prefrontal cortex). The other was located over a point midway between F4 and Fp2 (right dorsolateral prefrontal cortex and left prefrontal cortex). An extracephalic positions were used for the reference electrodes (cathodes) in order to avoid confounding effects from inhibitory cathodal effects at other cortical sites. The reference electrodes were placed on bilateral forearms. Stimulation was applied at an intensity of 2 milliampere (mA) (current density=1.14 A/square meter) for 20 min, twice-daily on 5 consecutive weekdays (total charge density=2736 C/square meter).

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 9, 2018
• Study Start: July 17, 2017
• Primary Completion: September 21, 2018
• Study Completion: September 21, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)