The Efficacy of Neural Stimulation in Individuals With Schizophrenia

NCT05746494 | Completed Results FDA Device

• 1 other identifier: 22-630
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning.

Conditions

Schizophrenia; Schizo Affective Disorder

Outcome Measures

Primary Outcomes (4)

• The State Social Paranoia Scale (SSPS)

  Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.

  The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation

• Ecological Momentary Assessment (EMA)-Based Paranoia

  Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can't trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.

  Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)

• Birchwood Social Functioning Scale (SFS)

  Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).

  The assessment was completed 30 minutes after completion of the active/sham stimulation

• Ecological Momentary Assessment (EMA)-Based Social Functioning

  Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).

  Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)

Secondary Outcomes (4)

• The Trustworthiness Task

  The assessment was completed 30 minutes after completion of the active/sham stimulation

• The Scrambled-sentences Task (SST)

  The assessment was completed 30 minutes after completion of the active/sham stimulation

• The Ambiguous Intentions Hostility Questionnaire (AIHQ)

  The assessment was completed 30 minutes after completion of the active/sham stimulation

• The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)

  The assessment was completed 30 minutes after completion of the active/sham stimulation

Study Arms (2)

Active anodal tDCS first, then Sham tDCS

EXPERIMENTAL

Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.

Device: tDCS

Sham tDCS first, then Active anodal tDCS

SHAM COMPARATOR

Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.

Device: tDCS

Interventions

tDCS DEVICE

active anodal tDCS and sham tDCS

Active anodal tDCS first, then Sham tDCS; Sham tDCS first, then Active anodal tDCS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age = 18-64
• Diagnosed with schizophrenia or schizoaffective disorder
• Having current (in the past week) or recent (in the past month) paranoia

You may not qualify if:

• Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ \< 70
• Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
• Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
• History of electroconvulsive therapy
• Lack of proficiency in English
• Substance use disorder not in remission in the past 6 months
• Any implanted devices such as pace maker, neurostimulator
• Pregnancy

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

The Unversity of Texas at Dallas

Richardson, Texas, 75080, United States

Location

Related Publications (1)

• Fan L, Carrico S, Zhu Y, Ackerman RA, Pinkham AE. Transcranial Direct Current Stimulation Improves Paranoia and Social Functioning in Schizophrenia: A Randomized Clinical Trial. Biol Psychiatry. 2025 Jul 15;98(2):135-143. doi: 10.1016/j.biopsych.2025.01.011. Epub 2025 Jan 22.

  PMID: 39855408 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

The inherent limitations of the assessment tools for measuring social functioning in the lab may have impacted the findings.

Results Point of Contact

• Title: Dr. Linlin Fan
• Organization: University of Texas at Dallas

linlin.fan@utdallas.edu; linlinfan@um.edu.mo

+(853) 8822 4226

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 27, 2023
• Study Start: November 21, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)