Back to resultsThe Efficacy of Neural Stimulation in Individuals With Schizophrenia
Primary Purpose
Schizophrenia, Schizo Affective Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Age = 18-60 Diagnosed with schizophrenia or schizoaffective disorder Having current (in the past week) or recent (in the past month) paranoia Exclusion Criteria: 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
Sites / Locations
- The Unversity of Texas at DallasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active anodal tDCS first, then Sham tDCS
Sham tDCS first, then Active anodal tDCS
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by the State Social Paranoia Scale (SSPS). Participants will indicate 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.
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items (e.g., "I snap at people when they do little things that irritate me") assessing pathological hostility on a 4-point scale (0 = very false or often false, 3 = very true or often true), with higher total scores indicating more hostility (range = 0-30).
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Five ambiguous scenarios will be presented to participants, and they will be asked to give reasons why each situation happened, indicate how much they think that people did this to them on purpose, how angry they are, how much they will blame others, and what they will do about it. Responses will be recorded verbatim or based on 6-point (if the behavior is on purpose) and 5-point (how angry they are, how much they will blame others) Likert scales. For the open-ended questions, hostility and aggression biases will be rated by three independent, trained raters using a 5-point Likert scale (1 = not hostile/aggressive at all, 5 = very hostile/aggressive). Inter-rater reliability will be computed by ICC among all the raters, with ICC > .80 being acceptable.
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by the Scrambled-sentences task (SST)
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by the Trustworthiness Task
Paranoid Ideation for Active vs. Sham Stimulation
Paranoid ideation will be measured by EMA (i.e., questions about feelings of paranoia in daily life).
Social functioning for Active vs. Sham Stimulation
Social functioning will be 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).
Social functioning for Active vs. Sham Stimulation
Social functioning will be measured by EMA (i.e., questions about daily interactions with others)
Social functioning for Active vs. Sham Stimulation
Social functioning will be measured by EMA (i.e., questions about daily experience in social interactions).
Social functioning for Active vs. Sham Stimulation
Social functioning will be measured by EMA (i.e., questions about daily expectations of social interactions).
Secondary Outcome Measures
Full Information
NCT ID
NCT05746494
First Posted
February 2, 2023
Last Updated
February 24, 2023
Sponsor
The University of Texas at Dallas
1. Study Identification
Unique Protocol Identification Number
NCT05746494
Brief Title
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Official Title
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
Detailed Description
Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques [e.g., transcranial direct current stimulation (tDCS)] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.
This project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active anodal tDCS first, then Sham tDCS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS first, then Active anodal tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
active anodal tDCS and sham tDCS
Primary Outcome Measure Information:
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by the State Social Paranoia Scale (SSPS). Participants will indicate 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.
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items (e.g., "I snap at people when they do little things that irritate me") assessing pathological hostility on a 4-point scale (0 = very false or often false, 3 = very true or often true), with higher total scores indicating more hostility (range = 0-30).
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Five ambiguous scenarios will be presented to participants, and they will be asked to give reasons why each situation happened, indicate how much they think that people did this to them on purpose, how angry they are, how much they will blame others, and what they will do about it. Responses will be recorded verbatim or based on 6-point (if the behavior is on purpose) and 5-point (how angry they are, how much they will blame others) Likert scales. For the open-ended questions, hostility and aggression biases will be rated by three independent, trained raters using a 5-point Likert scale (1 = not hostile/aggressive at all, 5 = very hostile/aggressive). Inter-rater reliability will be computed by ICC among all the raters, with ICC > .80 being acceptable.
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by the Scrambled-sentences task (SST)
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by the Trustworthiness Task
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Paranoid Ideation for Active vs. Sham Stimulation
Description
Paranoid ideation will be measured by EMA (i.e., questions about feelings of paranoia in daily life).
Time Frame
Change in daily paranoia feelings will be 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)
Title
Social functioning for Active vs. Sham Stimulation
Description
Social functioning will be 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).
Time Frame
The assessment will be completed 30 minutes after completion of the active/sham stimulation
Title
Social functioning for Active vs. Sham Stimulation
Description
Social functioning will be measured by EMA (i.e., questions about daily interactions with others)
Time Frame
Change in daily interactions will be 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)
Title
Social functioning for Active vs. Sham Stimulation
Description
Social functioning will be measured by EMA (i.e., questions about daily experience in social interactions).
Time Frame
Change in daily experience in social interactions will be 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)
Title
Social functioning for Active vs. Sham Stimulation
Description
Social functioning will be measured by EMA (i.e., questions about daily expectations of social interactions).
Time Frame
Change in daily expectations of social interactions will be 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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age = 18-60
Diagnosed with schizophrenia or schizoaffective disorder
Having current (in the past week) or recent (in the past month) paranoia
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linlin Fan
Phone
6822486951
Email
linlin.fan@utdallas.edu
Facility Information:
Facility Name
The Unversity of Texas at Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linlin Fan
Email
linlin.fan@utdallas.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Neural Stimulation in Individuals With Schizophrenia
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