Non-invasive Brain Stimulation Using Tdcs of the Third (of Many) Visual Pathways
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNathan Kline Institute for Psychiatric Research
About this trial
This study investigates the ability of transcranial direct current stimulation (tDCS) applied over the motion processing area of the brain (area MT) to improve face emotion recognition (FER) ability. tDCS is a type of non-invasive brain stimulation in which low level currents are applied over the scalp to influence underlying brain function. In schizophrenia, impaired ability to detect facial motion has been shown to contribute to impaired FER, which, in turn, leads to difficulties in social cognition and poor social outcome. The study will use both fMRI and EEG to measure brain function while participants view moving dot and dynamic face stimuli. Analyses will compare changes in fMRI and EEG activity in individuals receiving active vs. sham stimulation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subject, age 18-55
Competent and willing to sign informed consent
No more than moderately ill
SCID DSM-5 diagnosis of Sz/SzAff
Disqualifiers
Significant neurological illness or history of significant head trauma
Unstable physical illness or significant auditory/visual deficits that might interfer
Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
Contraindications to tDCS including metal implant, pacemaker, history of seizure, traumatic brain injury or stroke
Trial design
Design model
Parallel
Treatments tested in this trial
transcranial direct current stimulation
DevicetDCS will be applied over cortical region MT+
Sham stimulation
DeviceRamp up/ramp down to simulate scalp sensation associated with tDCS. No sustained current flow
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Active tDCSExperimental treatment 1 intervention
Group B: Sham tDCSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
MT+ activation as determined using fMRI
Magnitude of activation in area MT+ during random dot kinematogram (RDK) stimulation measured by the beta weight of the BOLD fMRI signal, expressed in units of percentage signal change
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 102
MT+ activation as determined using event-related potentials (ERP)
Amplitude of the ERP response to random dot kinematogram (RDK) stimulation, measured in microvolts
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 3Secondary outcomes
1
Activation of the third visual pathway (regions pSTS/mSTS) during a dynamic face emotion recognition (FER) task, as measured using fMRI
Magnitude of activation in areas pSTS and mSTS during the dynamic FER task as measured by the beta weight of the BOLD fMRI signal, expressed in units of percentage signal change
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 102
Fractional occupancy (FO) of the TVP CAP state
Fractional occupancy of the TVP CAP state during the NV-fMRI stimuli (Despicable me, Sherlock), as measured in percentage units
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 103
Activation of the third visual pathway (regions pSTS/mSTS) during a dynamic face emotion recognition (FER) task, as measured using ERP
Amplitude of the ERP response to dynamic emotional face stimuli, measured in microvolts
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 34
Motion discrimination threshold
% motion of the random dot kinetamatogram (RDK) stimuli needed for detection of motion, measured in percent
Time frame
Simultaneously with the administration of the active or sham tDCS intervention during study day 3Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Nathan Kline Institute for Psychiatric Research
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Columbia University
Collaborator
Research Foundation for Mental Hygiene, Inc.
Collaborator
Source ClinicalTrials.gov