Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation

NCT03062553 | Withdrawn DMC

• 1 other identifier: H16-01791
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to use a form of neuromodulation, known as transcranial alternating current stimulation (tACS), to improve the effectiveness of the metacognitive training (MCT) program for treatment of delusions in schizophrenia. tACS is a non-invasive brain stimulation method utilizing weak electrical currents applied to the head to influence neural firing (Antal \& Paulus, 2013). Brain regions implicated in delusional thinking will be targeted in the hopes of promoting thinking patterns that will allow participants to question delusional beliefs, reducing the severity of delusions and increasing the positive effects of MCT (Whitman et al., in press; Whitman, Minz \& Woodward, 2013). Electroencephalogram (EEG) and behavioural assessments will be used to measure treatment effects. However, before tACS will be administered to individuals experiencing delusions associated with schizophrenia we will conduct various control-phase (pilot) studies to gain a better understanding on how tACS temporarily alters performance on cognitive processes by biasing dominant patterns of oscillations. The objective of the pilot studies is to establish the effectiveness of the EGI GTEN system in modulating brain oscillations in the cortex of healthy participants by means of transcranial alternating current stimulation (tACS). In this control/pilot phase of our study, we aim to establish that we can induce changes in the power of a specific frequency band in targeted cortical regions with neuromodulation using the GTEN system, and we will assess whether doing so temporarily alters performance on simple cognitive and perceptual processes in healthy controls. This will be the first step towards translating our stimulation protocol to the patient population for our primary study of interest (tACS as an adjunct to metacognitive training for delusions in psychosis).

Conditions

Schizophrenia; Psychosis; Delusions

Outcome Measures

Primary Outcomes (1)

• Psychotic Symptom Rating Scale

  Delusion severity will be measured using the Delusions Scale of the Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, \& Faragher, 1999). The PSYRATS Delusion Scale measures specific aspects of delusions such as conviction and impact on thinking.

  8 weeks post-treatment

Secondary Outcomes (6)

• Scale for the Assessment of Negative Symptoms

  8 weeks post-treatment

• Scale for the Assessment of Positive Symptoms

  8 weeks post-treatment

• Signs and Symptoms of Psychotic Illness

  8 weeks post-treatment

• Jumping to Conclusions Task

  8 weeks post-treatment

• Bias Against Disconfirmatory Evidence Task

  8 weeks post-treatment

Study Arms (3)

MCT + Neuromodulation (MCT-N)

EXPERIMENTAL

Participants (n=50) randomly assigned to the MCT-N condition will undergo transcranial alternating current stimulation (tACS) prior to participation in MCT. Neuromodulation involving tACS will target increasing the power of the alpha band at dorsomedial prefrontal regions, and this is expected to also decrease the power of the beta band in ventro-medial regions. This will be confirmed by EEG recordings and source estimation during a task. The Metacognitive Training (MCT) group intervention will consist of an 8-module cycle occurring twice a week for 4 weeks, for a total of 8 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects.

Behavioral: Metacognitive Training (MCT); Device: transcranial alternating current stimulation (tACS)

Sham/MCT group (MCT- S)

EXPERIMENTAL

Participants (n=50) randomly assigned to the Sham/MCT (MCT-S) condition will undergo the application of random patterns of low-grade currents to the same brain region as the neuromodulation condition prior to participation in MCT. MCT is a four week program with eight one-hour sessions. MCT can be obtained online at no cost (www.uke.de/mkt). This experimental intervention will consist of an 8-module cycles occurring twice a week for 4 weeks, for a total of 8 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects.

Behavioral: Sham/MCT

Neuromodulation/Treatment as Usual TAU-N

EXPERIMENTAL

Participants (n=50) randomly assigned to the Neuromodulation/TAU (TAU - N) condition will undergo transcranial alternating current stimulation (tACS) prior to being placed on the TAU waitlist. Neuromodulation involving tACS will target increasing the power of the alpha band at dorsomedial prefrontal regions, and this is expected to also decrease the power of the beta band in ventro-medial regions. This will be confirmed by EEG recordings and source estimation during a task. TAU is a four week waitlist control group.

Device: transcranial alternating current stimulation (tACS)

Interventions

Metacognitive Training (MCT) BEHAVIORAL

MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions.

MCT + Neuromodulation (MCT-N)

Sham/MCT BEHAVIORAL

The Sham/MCT group will include application of random patterns of low-grade currents to the same brain region as the neuromodulation condition. MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions.

Also known as: Metacognitive Training (MCT)

Sham/MCT group (MCT- S)

transcranial alternating current stimulation (tACS) DEVICE

tACS is a non-invasive brain stimulation technique in which a weak electrical current is applied to the head. The current passing through the brain produces small changes in the excitability of the brain regions falling within the current flow. The current occur in an alternating manner (University of California-Berkeley, 2015).

Also known as: oscillation-targeted neuromodulation

MCT + Neuromodulation (MCT-N); Neuromodulation/Treatment as Usual TAU-N

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between the ages of 19 to 60 years with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, or a mood disorder with psychotic features will be recruited for this study.

You may not qualify if:

• An inability to read and write in English. Participants must be have used English on a daily basis for at least 5 years, and must be able to understand the consent form and give written consent.
• Participants with an IQ score of 80 or lower.
• A history of severe neurological disorder and those with severe manifestations of hostility, megalomania, formal thought disorder and suspiciousness will also be excluded from the analysis.
• Subjects who are consistently disrupting the treatment group might be asked to leave, this will be at the discretion of the group instructor.
• A history of neurological problems (e.g., stroke, aneurysm, Parkinson's, Multiple Sclerosis, encephalitis, meningitis, etc.)
• History of seizure disorder or family history of seizure disorder.
• History of migraines or other types of frequent severe headaches.
• Metallic implants in head.
• Severe head injury, frequent loss of consciousness and/or loss of consciousness greater than 30 minutes.
• Recently suffered a serious concussion
• Pregnancy
• Very fatigued and/or recently experienced severe sleep disturbances
• Medication known to increase risk of stroke and/or seizure.
• Suffer from severe current substance dependence
• Have a psychosis that is a direct consequence of substance abuse

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

UBC Hospital - Detwiller Pavilion

Vancouver, British Columbia, V6T 2A1, Canada

Location

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Related Links

• University of California - Berkeley - Committee for Protection of Human Subjects
• MCT for Psychosis
• Constrained principal component analysis: a comprehensive theory.

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Delusions

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Todd S Woodward, PhD

  UBC Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: February 23, 2017
• Study Start: February 1, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 15, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)