Add-on HD Hf-tRNS Over Bilateral DLPFC for Treating Patients With Schizophrenia

NCT04038788 | Completed

• 1 other identifier: 2-107-03-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to investigate the effects of high-definition transcranial random noise stimulation over bilateral prefrontal cortex on psychopathological symptoms, other clinical outcomes, autonomic functioning ,and brain oscillatory activity in schizophrenia patients.

Conditions

Schizophrenia; Schizoaffective Disorder; Psychotic Symptoms; Neurocognitive Dysfunction; Insight Impaired; Quality of Life; Psychosocial Impairment; Autonomic Imbalance; EEG With Abnormally Slow Frequencies

Outcome Measures

Primary Outcomes (1)

• Changes from baseline negative dimension score of Positive and Negative Syndrome Scale (PANSS) at the timepoint immediately after HD hf-tRNS, 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. 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).

  One month

Secondary Outcomes (20)

• Changes from baseline scores at Personal and Social Performance scale (PSP) at the timepoint immediately after HD hf-tRNS, at one-week and one-month follow-ups.

  One month

• Changes from baseline scores of the Global Assessment of Functioning (GAF) Scale of the DSM-IV at the timepoint immediately after HD hf-tRNS, at one-week and one-month follow-ups.

  One month

• Changes from baseline scores of the Clinical Global Impression (CGI) rating scales at the timepoint immediately after HD hf-tRNS, at one-week and one-month follow-ups.

  One month

• Changes from baseline scores of the self-reported version of the graphic personal and social performance scale (SRGPSP) at the timepoint immediately after HD hf-tRNS, and at one-week follow-up.

  One week

• 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 HD hf-tRNS, at one-week and one-month follow-up.

  One month.

Study Arms (2)

Active tRNS

ACTIVE COMPARATOR

In active tRNS condition, random noise was delivered by a battery-operated device (Eldith DC stimulator Plus, neuroConn, Ilmenau, Germany) via 5 carbon rubber electrodes (1 cm radius, high-definition 4 × 1 rings configuration with a gel layer of 2.0 mm), with 2 mA amplitude, offset at 1 mA, frequency 100-640 Hz, for 20 min with 15 s ramp-in/ramp-out. The combined impedance of all electrodes was kept below 15 kΩ, as measured by NeuroConn DC stimulator Plus device, using electrolyte gel. The anode was placed over International 10-10 electrode position AF3 (a point midway between F3 and Fp1), with cathodes (reference electrodes) at AF4, F2, F6 and FC4. Stimulation was applied at an intensity of 2 milliampere (mA) for 20 min, twice-daily on 5 consecutive weekdays. All patients in the active stimulation group were maintained on their antipsychotic medications throughout the study period.

Device: HD hf-tRNS

Sham treatment

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 group were maintained on their antipsychotic medications throughout the study period.

Device: HD hf-tRNS

Interventions

HD hf-tRNS DEVICE

See detail in arm/group descriptions regarding the intervention.

Active tRNS; Sham treatment

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 ≧ 1 year.
• Being on an adequate therapeutic dose of antipsychotics for at least 8 weeks prior to enrolment.
• Positive and Negative Syndrome Scale (PANSS scale) total score \< 120 (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 a history of seizures.
• Having contraindications for transcranial electrical stimulation or transcranial magnetic stimulation, e.g., implanted brain medical devices or metal in the head.
• Having a 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, Lin YY, Tzeng NS, Kao YC, Chang HA. Adjunct high-frequency transcranial random noise stimulation over the lateral prefrontal cortex improves negative symptoms of schizophrenia: A randomized, double-blind, sham-controlled pilot study. J Psychiatr Res. 2021 Jan;132:151-160. doi: 10.1016/j.jpsychires.2020.10.008. Epub 2020 Oct 16.

  PMID: 33096356 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognition Disorders

Condition Hierarchy (Ancestors)

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, 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, Associate Professor

Model Details: In active tRNS condition, random noise was delivered by a battery-operated device (Eldith DC stimulator Plus, neuroConn, Ilmenau, Germany) via 5 carbon rubber electrodes (1 cm radius, high-definition 4 × 1 rings configuration with a gel layer of 2.0 mm), with 2 mA amplitude, offset at 1 mA, frequency 100-640 Hz, for 20 min with 15 s ramp-in/ramp-out. The combined impedance of all electrodes was kept below 15 kΩ, as measured by NeuroConn DC stimulator Plus device, using electrolyte gel. The anode was placed over International 10-10 electrode position AF3 (a point midway between F3 and Fp1), with cathodes (reference electrodes) at AF4, F2, F6 and FC4. Stimulation was applied at an intensity of 2 milliampere (mA) for 20 min, twice-daily on 5 consecutive weekdays.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 31, 2019
• Study Start: October 24, 2018
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: July 31, 2019

Record last verified: 2019-07

Locations

TW (1)