Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia

NCT02975973 | Completed Results DMC FDA Device

• 1 other identifier: H-41815
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive impairments in schizophrenia are the most debilitating aspect of the illness and poorly treated by current medications. This study investigates transcranial direct current stimulation (tDCS) - a safe, noninvasive weak electrical current delivery to stimulate brain function - as a novel therapeutic for cognition in schizophrenia. Integrating neurostimulation, electrophysiology and neuroimaging, this project aims to study tDCS effects on cognition by verifying therapeutic target engagement, evaluating the tolerability of tDCS sessions, and optimizing treatment parameters.

Conditions

Schizophrenia; Psychosis

Keywords

tDCS; cognitive control; EEG; gamma oscillations

Outcome Measures

Primary Outcomes (2)

• tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging

  Change from Baseline to week 1 as measured by modulation of fMRI BOLD signal in DLPFC in the context of cognitive control task performance.

  1 week

• tDCS Engagement of DLPFC Activity Indexed by Modulation of Frontal Cortical Gamma Oscillations

  Change from Baseline to week 1 as measured by EEG frontal gamma oscillations in the context of cognitive control task performance

  1 week

Secondary Outcomes (2)

• Optimal tDCS Strength for DLPFC Engagement

  1 Week

• Tolerability and Feasibility of Multi-session tDCS in Schizophrenia

  1 week

Study Arms (4)

2.5mA

EXPERIMENTAL

Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.

Device: transcranial direct current stimulation

2.0mA

EXPERIMENTAL

Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.

Device: transcranial direct current stimulation

1.5mA

EXPERIMENTAL

Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.

Device: transcranial direct current stimulation

0mA

SHAM COMPARATOR

This will be an active sham involving transcranial direct current stimulation, though stimulation will be brief (15 msec) and have low current (0.11 mA) pulses every 550 ms.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation DEVICE

transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.

0mA; 1.5mA; 2.0mA; 2.5mA

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-35 years;
• within first five years of antipsychotic treatment;
• on stable doses of antipsychotic medication for at least one month;
• Clinically stable as defined by Clinical Global Impression-Severity scale (CGI-S) less than or equal to 4 (moderately ill);
• Mild to severe cognitive impairment in MATRICS Consensus Cognitive Battery (composite scores \<40);
• DSM-5 MINI 7.0.2 criteria for schizophrenia or schizoaffective by patient SCID

You may not qualify if:

• Mental retardation as defined by pre-morbid IQ by Wechsler Test of Adult Reading at screening \<70 or Spanish Word Accentuation Test;
• significant head injury;
• History of severe medical or neurological illnesses
• pregnancy or postpartum (\<6 weeks after delivery or miscarriage);
• inability to provide informed consent;
• significant color blindness that affects task performance;
• Positive urine drug screen (exception for marijuana) or presence of substance use disorder within 1 month;
• Currently on benzodiazepines or mood stabilizers affecting GABA

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

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

Despite concerted and exhaustive subject recruitment efforts, the total number of patients completing the protocol was minimal. As such the sample size was inadequate for deriving any meaningful descriptive statistics or statistical comparisons.

Results Point of Contact

• Title: Raymond Cho
• Organization: Baylor College of Medicine

Raymond.Cho@bcm.edu

713-798-7781

Study Officials

• Raymond Cho, M.D., M.Sc.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 23, 2016
• First Posted: November 29, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: November 25, 2020
• Results First Posted: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)