N/A N=12 Randomized Double-blind Other

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

Chronic Schizophrenia

Bottom Line

View on ClinicalTrials.gov: NCT02421146 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcome: Primary: Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale — 7; 5.25; -1.5; -1.33 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcranial direct current stimulation (Device); Transcranial direct current stimulation - Sham (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Northwell Health
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Cognition on the RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) Scale	7; 5.25; -1.5; -1.33	—
SECONDARY Cognition on the RBANS ( Repeatable Battery for the Assessment of Neuropsychological Status) Scale. Change Between 26th Day and Baseline.	0.5; -7; -9.5; -0.7	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02421146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.