The Effects of tDCS on Auditory Hallucination, Insight, Neurocognitive Function and HRV in Patients With Schizophrenia

NCT03388554 | Completed DMC

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

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.

Conditions

Schizophrenia; Schizoaffective Disorder; Auditory Hallucination, Verbal; Neurocognitive Dysfunction; Autonomic Imbalance; Psychosocial Impairment; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Changes from baseline scores of Auditory Hallucination Rating Scale (AHRS) at the timepoint immediately after tDCS, at one month and three months after tDCS.

  A clinician-administered rating scale to measure the severity of auditory (verbal) hallucination of the patients with schizophrenia spectrum disorder.

  Three months.

Secondary Outcomes (14)

• 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 Digit span (forward and backward)

  One month.

• Changes from baseline results of Finger tapping test

  One month.

• Changes from baseline results of Continuous Performance (CPT, version 2.0)

  One month.

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www. neuroconn.de/dc-stimulator\_plus\_en/) was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 square centimeter). The anode was placed with the middle of the electrode over a point midway between F3 and FP1 (left dorsolateral prefrontal cortex and left prefrontal cortex). The cathode was located over a point midway between T3 and P3 (left temporo-parietal junction). Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. The twice daily sessions were separated by at least 3 hours. 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

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:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hallucinations; Cognition Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; 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: Head of Laboratory of Psychophysiology, Department of Psychiatry, Principal Investigator, Attending Psychiatrist, Assistant Professor

Model Details: Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www. neuroconn.de/dc-stimulator\_plus\_en/) was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 square centimeter). The anode was placed with the middle of the electrode over a point midway between F3 and FP1 (left dorsolateral prefrontal cortex and left prefrontal cortex). The cathode was located over a point midway between T3 and P3 (left temporo-parietal junction). Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. The twice daily sessions were separated by at least 3 hours.

Study Record Dates

• First Submitted: December 24, 2017
• First Posted: January 3, 2018
• Study Start: July 1, 2016
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

TW (1)