Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02975973 |
Other study ID # |
H-41815 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2016 |
Est. completion date |
June 2019 |
Study information
Verified date |
November 2020 |
Source |
Baylor College of Medicine |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
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.