Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation (tACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03062553
Recruitment Status : Withdrawn (Testing for this study remained in the pilot stages due to optimization of the tACS equipment. There are no clinical results to report.)
First Posted : February 23, 2017
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
Vancouver Coastal Health Research Institute
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Todd Woodward, University of British Columbia

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).


Condition or disease Intervention/treatment Phase
Schizophrenia Psychosis Delusions Behavioral: Metacognitive Training (MCT) Behavioral: Sham/MCT Device: transcranial alternating current stimulation (tACS) Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancement of Treatment of Delusions in Schizophrenia Through Neuromodulation
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : December 15, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MCT + Neuromodulation (MCT-N)

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)
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).
Other Name: oscillation-targeted neuromodulation

Experimental: Sham/MCT group (MCT- S)

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

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.

Other Name: Metacognitive Training (MCT)

Experimental: Neuromodulation/Treatment as Usual TAU-N

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)
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).
Other Name: oscillation-targeted neuromodulation




Primary Outcome Measures :
  1. Psychotic Symptom Rating Scale [ Time Frame: 8 weeks post-treatment ]
    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.


Secondary Outcome Measures :
  1. Scale for the Assessment of Negative Symptoms [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Scale for the Assessment of Negative Symptoms (SANS; Andreasen, 1984).

  2. Scale for the Assessment of Positive Symptoms [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Scale for the Assessment of Positive Symptoms (SAPS; Andreasen, 1984).

  3. Signs and Symptoms of Psychotic Illness [ Time Frame: 8 weeks post-treatment ]
    General psychopathology will be assessed using the Signs and Symptoms of Psychotic Illness (SSPI; Liddle et al., 2002).

  4. Jumping to Conclusions Task [ Time Frame: 8 weeks post-treatment ]
    A cognitive biases commonly associated with delusions in schizophrenia will be evaluated using the "jumping to conclusions (JTC) task" (also known as the "fish task"). This task will be carried out on computer tablets. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).

  5. Bias Against Disconfirmatory Evidence Task [ Time Frame: 8 weeks post-treatment ]
    A cognitive biases commonly associated with delusions in schizophrenia will be evaluated using the "bias against disconfirmatory evidence (BADE) task". This task will be carried out on computer tablets. These tasks were developed, in part, by the principal investigator and have been described in previous research (Lecomte & Woodward 2005; Woodward 2006a; Woodward 2006b; Woodward 2007; Moritz & Woodward 2005; Woodward 2009).

  6. Electroencephalography Reasoning Bias (Evidence Matching Tasks) [ Time Frame: 8 weeks post-treatment ]
    Subjects will be assessed using electroencephalography (EEG) while they complete tasks in which they must determine whether two pieces of information match, in order to quantify the reactivity of the neural networks believed to be responsible for evidence matching (e.g., anterior-cingulate-based network) and integration of disconfirmatory evidence (bilateral prefrontal-based network). These cognitive bias tasks are the "jumping to conclusions task" (or "fish task") and the "bias against disconfirmatory evidence task" previously described, and were developed in part by the principal investigator.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

For control-phase studies:

Subjects. We will recruit 440 participants total in the "Enhancement of Treatment of Delusions in Schizophrenia through Neuromodulation" study H16-01791; The current protocol describes the methods to be used in the Control Phase of our research, during which we will recruit 290 healthy controls between 19 and 60 years in order to establish proof-of-concept for using GTEN tACS in modulating brain oscillations and performance on simple cognitive tasks.

Exclusion criteria for healthy controls:

  • 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. While there is no direct evidence to suggest that tACS increases the risk of seizure in those with a history of seizure disorder in their family, research in this area is still relatively recent (< 15 years). Given the unlikely potential for an unknown elevated risk of seizure, we are including this as a conservative precautionary exclusion factor.
  • History of migraines or other types of frequent severe headaches. tACS can induce a headache in those prone to migraines and other forms of severe headaches.
  • Presence of metallic implants in head.
  • History of severe head injury, frequent loss of consciousness and/or loss of consciousness greater than 30 minutes.
  • Recent history of a serious concussion
  • Current pregnancy.
  • Symptoms of severe fatigued and/or recent experience of severe sleep disturbance.
  • Medication known to increase risk of stroke and/or seizure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03062553


Locations
Layout table for location information
Canada, British Columbia
UBC Hospital - Detwiller Pavilion
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Brain & Behavior Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Todd S Woodward, PhD UBC Professor
Additional Information:
Publications:
Moritz, S., Veckenstedt, R., Vitzthuma, F., Köthera, U., & Woodward,T.S., Metacognitive training in schizophrenia. Theoretical rationale and administration, in Social Cognition In Schizophrenia: From Evidence to Treatment, David L. Roberts and D.L. Penn, Editors. 2013, Oxford University Press: Oxford. p. 358-383.

Layout table for additonal information
Responsible Party: Todd Woodward, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03062553    
Other Study ID Numbers: H16-01791
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be reviewed in the aggregate. Individual data will not be analyzed or shared with participants.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Delusions
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Behavioral Symptoms