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

Chronic Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421146
• Other study ID #: 14-623
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: September 12, 2016

Study information

• Verified date: March 2018
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 12, 2016
• Est. primary completion date: September 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Schizophrenia
• Schizophrenia

Intervention

Device:
• Transcranial direct current stimulation
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.
• Transcranial direct current stimulation - Sham
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.

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline (0th day), 26th day