SchizophreniaNCT02975973

Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia

A study testing transcranial direct current stimulation in people with Schizophrenia and Psychosis, run by Baylor College of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Schizophrenia, Psychosis
What is being tested?: transcranial direct current stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 15 participants
Where: 1 siteUnited States
Study dates: Nov 2016to Jun 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Baylor College of Medicine
Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

Cognitive deficits are a strong predictor of functional outcome in schizophrenia, yet poorly remediated by current treatments. Disturbances in dorsolateral prefrontal cortex (DLPFC) function underlie core impairments such as in cognitive control and thus represent a critical target for novel therapeutics. Initial studies indicate transcranial direct-current stimulation (tDCS) may be effective in reducing symptoms due to DLPFC dysfunction. While tDCS potentially represents an exciting, novel therapeutic advance, a number of basic questions should be addressed prior to conducting larger-scale clinical trials, including: verifying therapeutic target engagement, optimizing treatment parameters, and evaluating for meaningful clinical effects. Recent studies employing tDCS to enhance prefrontal cortical function in schizophrenia applied stimulating electrodes over the left frontal scalp region, putatively targeting the left DLPFC. However, explicit confirmation of such target engagement is lacking. Further, EEG studies have demonstrated close links of frontal cortical gamma oscillations to cognitive control processes but modulation of this critical physiologic process has not been investigated. Accordingly, the primary aim of this study is to employ multimodal imaging to explicitly test for the assumed DLPFC engagement (fMRI) and modulation of frontal gamma activity (EEG) by tDCS. This study will also investigate the optimization of tDCS application parameters. Analogous to dose-finding investigations in drug studies, we will conduct a parametric investigation of optimal current strengths. Also, while there is extensive evidence for tolerability of single session tDCS, confirmation of feasibility of multisession optimized protocols in schizophrenia is lacking and so will be explicitly evaluated.

In summary, a successful outcome of this study would provide tDCS the sound mechanistic and methodologic basis for more definitive testing in large-scale clinical trials as a highly innovative therapeutic intervention for cognitive impairments in schizophrenia.

Conditions: Schizophrenia, Psychosis
Being tested: transcranial direct current stimulation
Keywords: tDCS, cognitive control, EEG, gamma oscillations
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial direct current stimulationDevice
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.

Study groups in NCT02975973
Study group	Role	What they receive
2.5mA	Experimental	Active stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation. Receives: Device: transcranial direct current stimulation
2.0mA	Experimental	Active stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation. Receives: Device: transcranial direct current stimulation
1.5mA	Experimental	Active stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation. Receives: 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. Receives: Device: transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Measured: 1 week

Secondary outcomes (2)

Optimal tDCS Strength for DLPFC Engagement
Change from baseline to 1 week in DLPFC engagement across conditions (1.5 vs 2.0 vs 2.5 mA)
Measured: 1 Week
Tolerability and Feasibility of Multi-session tDCS in Schizophrenia
The percentage of participants able to complete the full study.
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jun 2019

First posted29 Nov 2016 (estimated)
Study startNov 2016
Primary completionJun 2019
Study completionJun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Baylor College of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02975973
Sponsor's protocol ID: H-41815
Status last verified: Nov 2020
First submitted: 23 Nov 2016
Last updated: 25 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Data will be open to sharing after primary findings of study have been published

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia
ClinicalTrials.gov ID: NCT02975973
Acronym / sponsor ID: H-41815
Conditions: Schizophrenia, Psychosis
Keywords: tDCS, cognitive control, EEG, gamma oscillations
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Baylor College of MedicineUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Nov 2016
Primary completion: Jun 2019 (actual)
Study completion: Jun 2019 (actual)
First posted: 29 Nov 2016 (estimated)
Results: Posted 25 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
2.5mA	Experimental	Device: transcranial direct current stimulationActive stimulation group will receive 20 minutes of 2.5 mA transcranial direct current stimulation.
2.0mA	Experimental	Device: transcranial direct current stimulationActive stimulation group will receive 20 minutes of 2.0 mA transcranial direct current stimulation.
1.5mA	Experimental	Device: transcranial direct current stimulationActive stimulation group will receive 20 minutes of 1.5 mA transcranial direct current stimulation.
0mA	Sham comparator	Device: transcranial direct current stimulationThis 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.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
transcranial direct current stimulationtranscranial 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.	Device	0mA, 1.5mA, 2.0mA, 2.5mA

Primary outcome

tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging
Time frame: 1 week
Change from Baseline to week 1 as measured by modulation of fMRI BOLD signal in DLPFC in the context of cognitive control task performance.
tDCS Engagement of DLPFC Activity Indexed by Modulation of Frontal Cortical Gamma Oscillations
Time frame: 1 week
Change from Baseline to week 1 as measured by EEG frontal gamma oscillations in the context of cognitive control task performance

2 secondary outcomes

Optimal tDCS Strength for DLPFC Engagement
Time frame: 1 Week
Tolerability and Feasibility of Multi-session tDCS in Schizophrenia
Time frame: 1 week

Results and safety

Results posted to the registry on 25 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2.5mA	1	0
2.0mA	2	1
1.5mA	1	0
0mA (Active Placebo)	4	4

Primary outcome: tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging

Time frame: 1 week

Population analysed: Our analytic strategy involved defining regions of interest (ROI) derived from group averages across all study subjects but due to unforeseen circumstances, we recruited far too few subjects to derive meaningful group averages. Individual subject and by extension, condition-specific averages that are based on such ROIs, could therefore not be derived. However, we will upload our raw data to the National Data Archive to be accessed for any potential analyses with data pooled from other studies.

Primary outcome: tDCS Engagement of DLPFC Activity Indexed by Modulation of Frontal Cortical Gamma Oscillations

Time frame: 1 week

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Two Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2.5mA	0 of 1 (0%)	0 of 1 (0%)	0 of 1
2.0mA	1 of 2 (50%)	1 of 2 (50%)	0 of 2
1.5mA	0 of 1 (0%)	0 of 1 (0%)	0 of 1
0mA (Active Placebo)	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Data will be open to sharing after primary findings of study have been published

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond Cho, M.D., M.Sc. principal investigator

Baylor College of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation in people with Schizophrenia and Psychosis, run by Baylor College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.