NCT02421146

Brief Summary

The purpose of this project is to examine brain function before, during, and after the administration of tDCS (Transcranial Direct Current Stimulation). The brain can perform its job well or poorly depending on many things. The investigators will be using computer tasks and paper and pencil questionnaires to measure the relationship between brain performance and the administration of tDCS. In addition, the study team will be using functional magnetic resonance imaging (fMRI) and related imaging techniques to see how your brain works and compare it with the results we collected from the paper and pencil questionnaires. This study will enroll both schizophrenia patients as well as healthy volunteers without any major psychiatric disorder or physical illness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 30, 2018

Completed
Last Updated

April 30, 2018

Status Verified

March 1, 2018

Enrollment Period

1.5 years

First QC Date

April 13, 2015

Results QC Date

November 17, 2017

Last Update Submit

March 30, 2018

Conditions

Chronic Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale

    Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 12th day and baseline. Scores at 12th day and at baseline are calculated according to the RBANS standards as following: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. For the detailed procedures and ranges please see: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). "The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity". J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. It is a simple delta score: calculating the difference between 12th day and baseline.

    baseline (0th day), 12th day

Secondary Outcomes (1)

  • Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.

    baseline (0th day), 26th day

Study Arms (4)

Sham tDCS - Healthy Controls

SHAM COMPARATOR

The sham group session will contain 20 minute sessions of transcranial direct current stimulatio , but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.

Device: Transcranial direct current stimulation - Sham

tDCS - Healthy Controls

ACTIVE COMPARATOR

will receive real transcranial direct current stimulation. Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks

Device: Transcranial direct current stimulation

Sham tDCS - Patients

SHAM COMPARATOR

The sham group session will contain 20 minute sessions of transcranial direct current stimulation as well, but only the first minute will be with 2mA, then unbeknownst to the subject, the unblinded research assistant will turn off the stimulation.

Device: Transcranial direct current stimulation - Sham

tDCS - Patients

ACTIVE COMPARATOR

will receive real transcranial direct current stimulation . Real tDCS stimulation will involve ten 20 minute stimulations daily (at 2 mA anode over the left DLPFC while cathode over the right suborbital region) on 5 weekdays of two consecutive weeks

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulationDEVICE

Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.

Also known as: tDCS
tDCS - Healthy ControlstDCS - Patients
Transcranial direct current stimulation - ShamDEVICE

Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.

Also known as: tDCS
Sham tDCS - Healthy ControlsSham tDCS - Patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 18 and 60 years of age
  • Subject is competent to provide informed consent
  • Pt diagnosed with schizophrenia according to DSM V criteria.

You may not qualify if:

  • MRI contraindications
  • Person with any kind of neurostimulator or pacemaker, or built in electrical device even if it is MRI safe
  • Skin lesions at the site of electrodes and any documented head or neck dermatological disorder
  • Pregnancy
  • Any major neurological (seizures, sclerosis multiplex, etc) disorder
  • Individuals who are illiterate and/or visually impaired
  • Subjects with history of mental retardation, learning disorders or traumatic brain injury
  • Past or current history of any psychotic illness in the subject or in first degree family members
  • Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month.
  • Any use of any psychotropic medications (antipsychotics, SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Results Point of Contact

Title
Andrea Joanlanne
Organization
Psychiatry Research, The Zucker Hillside Hospital
ajoanlanne@northwell.edu
7184708898

Study Officials

  • Miklos Argyelan, MD

    The Zucker Hillside Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 13, 2015

First Posted

April 20, 2015

Study Start

April 1, 2015

Primary Completion

September 12, 2016

Study Completion

September 12, 2016

Last Updated

April 30, 2018

Results First Posted

April 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

via email request

Locations

US(1)