To Investigate the Effects of Transcranial Direct Current Stimulation on Auditory Hallucination, Insight, Neurocognitive Function, Heart Rate Variability, Psychosocial Functioning and Quality of Life in Patients With Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes from baseline scores of Auditory Hallucination Rating Scale (AHRS) at the timepoint immediately after tDCS, at one month and three months after tDCS.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The study aimed to investigate whether transcranial direct current stimulation could modify auditory hallucination, insight, neurocognitive function, heart rate variability, psychosocial functioning and quality of life in patients with schizophrenia.
Detailed Description
Transcranial direct current stimulation (tDCS), a novel, non-invasive and safe neuro-modulating technique, has been developed as a new therapeutic option for neuropsychiatric disorders. It encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes. Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. The technique was established in the 1950s and 1960s primarily in animals. In these early studies it was shown that subthreshold DC stimulation increases spontaneous neuronal activity if the anode is placed above or within the cortex, while exposure to cathodal polarity results in reduced activity. This is caused by a subthreshold membrane depolarization by anodal and a hyperpolarization by cathodal stimulation. It was demonstrated in humans that the after-effects of tDCS depend on modifications of NMDA receptor-efficacy. The after-effects of tDCS are blocked by the NMDA receptor antagonist dextromethorphan, and prolonged by the partial NMDA receptor-agonist D-cycloserine. This tDCS polarity-dependent alteration of NMDA receptor function seems to be initiated by the respective membrane potential shift and probably by the accompanying cortical activity modification,because it is prevented by the sodium channel blocker carbamazepine. Intraneuronal calcium concentration also contributes, because calcium channel antagonists eliminate the excitability-enhancing aftereffects of anodal tDCS. Recently, tDCS has been found to improve psychopathological symptoms (auditory hallucination in particular), cognitive deficits and insight of schizophrenia and also strengthen cardiac autonomic function in healthy subjects. Further replication studies are needed. The study aimed to investigate whether transcranial direct current stimulation could modify auditory hallucination, insight, neurocognitive function, heart rate variability, psychosocial functioning and quality of life in patients with schizophrenia. Study design: randomized double-blind, sham-controlled study design. Participants: 60 patients having a diagnosis of schizophrenia or schizoaffective with refractory auditory verbal hallucinations (defined as the persistence of daily auditory verbal hallucinations without remission in spite of antipsychotic medications at an adequate dosage for at least 3 months), aged 20-65 years. Others: see Arms and Interventions, Eligibility Criteria or Outcome Measures.
Investigators
Hsin-An Chang, MD
Head of Laboratory of Psychophysiology, Department of Psychiatry, Principal Investigator, Attending Psychiatrist, Assistant Professor
Tri-Service General Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients who met DSM-IV-TR criteria for schizophrenia or schizoaffective disorder were included in the study. All these patients showed refractory auditory verbal hallucinations,which are defined as the persistence of daily auditory verbal hallucinations without remission in spite of antipsychotic medications at an adequate dosage for at least 3 months.
Exclusion Criteria
- •Pregnancy or breastfeeding.
- •Having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence.
- •Having contraindications for transcranial electrical/magnetic stimulation.
- •Having intracranial metal foreign bodies.
- •Having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
Outcomes
Primary Outcomes
Changes from baseline scores of Auditory Hallucination Rating Scale (AHRS) at the timepoint immediately after tDCS, at one month and three months after tDCS.
Time Frame: Three months.
A clinician-administered rating scale to measure the severity of auditory (verbal) hallucination of the patients with schizophrenia spectrum disorder.
Secondary Outcomes
- 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.(Three months.)
- 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 results of Tower of London test at the timepoint immediately after tDCS and at one month after tDCS.(One month.)
- Changes from baseline results of Continuous Performance (CPT, version 2.0)(One month.)
- Changes from baseline scores of the brief version of questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF Taiwan version) at the timepoint immediately after tDCS and at one month after tDCS.(One month.)
- Changes from baseline scores of 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 results of Digit span (forward and backward)(One month.)
- Changes from baseline results of Finger tapping test(One month.)
- Changes from baseline heart rate variability (HRV) at the timepoint immediately after tDCS and at one month after tDCS.(One month.)
- Changes from baseline results of Wisconsin Card Sorting Test (WCST) at the timepoint immediately after tDCS and at one month after tDCS.(One month.)
- Changes from baseline results of Trail Making Test (TMT) 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.)
- Changes from baseline scores of the Taiwanese version of the Beck Cognitive Insight Scale (BCIS) at the timepoint immediately after tDCS and at one month after tDCS.(One month.)
- Changes from baseline scores of the Taiwanese version of the Self- Appraisal of Illness Questionnaire (SAIQ) at the timepoint immediately after tDCS and at one month after tDCS.(One month.)