Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation

NCT03062553 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-01-08

No results posted yet for this study

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

Interventions

BEHAVIORAL

Metacognitive Training (MCT)

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.

BEHAVIORAL

Sham/MCT

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.

DEVICE

transcranial alternating current stimulation (tACS)

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).

Sponsors & Collaborators

  • Vancouver Coastal Health Research Institute

    collaborator OTHER
  • Brain & Behavior Research Foundation

    collaborator OTHER
  • University of British Columbia

    lead OTHER

Principal Investigators

  • Todd S Woodward, PhD · UBC Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03062553 on ClinicalTrials.gov