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The Effect of Transcranial Direct Current Stimulation on Human Brains: A Neuroimaging Study

Primary Purpose

Chronic Schizophrenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Transcranial direct current stimulation - Sham
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Schizophrenia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Between 18 and 60 years of age
  2. Subject is competent to provide informed consent

    Additional inclusion criteria for schizophrenia group:

  3. Pt diagnosed with schizophrenia according to DSM V criteria.

Exclusion Criteria:

  1. MRI contraindications
  2. Person with any kind of neurostimulator or pacemaker, or built in electrical device even if it is MRI safe
  3. Skin lesions at the site of electrodes and any documented head or neck dermatological disorder
  4. Pregnancy
  5. Any major neurological (seizures, sclerosis multiplex, etc) disorder
  6. Individuals who are illiterate and/or visually impaired
  7. Subjects with history of mental retardation, learning disorders or traumatic brain injury

    Additional exclusion criteria for healthy group:

  8. Past or current history of any psychotic illness in the subject or in first degree family members
  9. Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month.
  10. Any use of any psychotropic medications (antipsychotics, SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.

Sites / Locations

  • Zucker Hillside Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Sham tDCS - Healthy Controls

tDCS - Healthy Controls

Sham tDCS - Patients

tDCS - Patients

Arm Description

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.

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.
Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 26th day and baseline. Scores at 26th day and at baseline are calculated according to the RBANS standards as the 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 26th day and baseline.

Full Information

First Posted
April 13, 2015
Last Updated
March 30, 2018
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT02421146
Brief Title
The Effect of Transcranial Direct Current Stimulation on Human Brains: A Neuroimaging Study
Official Title
The Effect of Transcranial Direct Current Stimulation on Human Brains: A Neuroimaging Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 12, 2016 (Actual)
Study Completion Date
September 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a placebo condition controlled double blind randomized prospective study where the study team plan to acquire clinical, neurocognitive and imaging data in schizophrenia patients and healthy controls. Those who are eligible for the study will be consented, and will be randomized into either group A or B. The length of the study is four weeks. Subjects in both groups will undergo the same procedure, except that while subjects from group A unbeknownst to them will receive only a sham stimulation of tDCS (placebo condition), the subjects from group B will receive real tDCS 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, while sham will contain 20 minute sessions 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. The subjects will be told that they can be given either a sham or real stimulation and will be asked at the end of the experiment to fill out a visual analog scale indicating their guess about being in the real or sham arm. Following the first two weeks of the study, there will be a follow up period of two weeks when no stimulation or sham will be administered. Subjects, raters, clinicians and most of the research persons will all be kept blind in regards to their placebo or stimulation status until the end of the study. Research persons analyzing neuroimgaing data will break blindness after subject leaves the study, to continuously monitor neuroimaging findings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Schizophrenia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS - Healthy Controls
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
tDCS - Healthy Controls
Arm Type
Active Comparator
Arm Description
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
Arm Title
Sham tDCS - Patients
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
tDCS - Patients
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation - Sham
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale
Description
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.
Time Frame
baseline (0th day), 12th day
Secondary Outcome Measure Information:
Title
Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.
Description
Standard neuropsychological assessment taking approximately 30 minutes. We report here the total score ndifference between 26th day and baseline. Scores at 26th day and at baseline are calculated according to the RBANS standards as the 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 26th day and baseline.
Time Frame
baseline (0th day), 26th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 18 and 60 years of age Subject is competent to provide informed consent Additional inclusion criteria for schizophrenia group: Pt diagnosed with schizophrenia according to DSM V criteria. Exclusion Criteria: 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 Additional exclusion criteria for healthy group: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miklos Argyelan, MD
Organizational Affiliation
The Zucker Hillside Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
via email request

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The Effect of Transcranial Direct Current Stimulation on Human Brains: A Neuroimaging Study

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