NIMH K23: Modulation of Frontoparietal Dynamics in Adolescent Working Memory Deficits
ConditionWorking Memory
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBradley Hospital
About this trial
Working memory (WM) deficits are a transdiagnostic feature of adolescent psychopathology that substantially contribute to poor clinical and functional outcomes. This proposal will utilize a multimodal neuroscientific approach to investigate whether non-invasive brain stimulation can modulate the neural mechanisms underlying adolescent WM deficits. Directly in line with NIMH priorities, the researchers will identify the contributing roles of prefrontal and parietal regions in WM processes, as well as identify optimal targets and parameters for novel brain-based treatments in adolescent psychopathology. This study is funded by the NIMH-K23
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide assent and have parent provide parental permission
English fluency of the participant and the legal guardian/parent
12-18 years
Parent rating on BRIEF-2 Working Memory: Greater than 1.0 SD above normative mean.
Disqualifiers
Intracranial pathology from a known genetic disorder (e.g., NF1, tuberous sclerosis) or from acquired neurologic disease (e.g. stroke, tumor), cerebral palsy, history of severe head injury, or significant dysmorphology
History of fainting spells of unknown or undetermined etiology that might constitute seizures
History of seizures, diagnosis of epilepsy, or immediate (1st degree relative) family history epilepsy
Any progressive (e.g., neurodegenerative) neurological disorder
Trial design
Design model
Crossover
Treatments tested in this trial
Active Intermittent Theta Burst Stimulation
DeviceStandard iTBS protocol with active coil
Sham Intermittent Theta Burst Stimulation
DeviceStandard iTBS protocol with active coil
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Active intermittent Theta Burst StimulationExperimental treatment 1 intervention
Group B: Sham intermittent Theta Burst StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Theta-Gamma Coupling After Sham iTBS
EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands. The change between pre and post a single iTBS session will be calculated.
Time frame
Theta-gamma coupling will be obtained immediately before (i.e., pre-iTBS) and after iTBS (i.e., post-iTBS). There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre-iTBS and post-iTBS is the outcome variable.2
Change in Theta-Gamma Coupling after Active iTBS
EEG recording will be obtained while the participant completes the Sternberg Spatial Working Memory Test (SWMT). The coupling between theta phase and gamma amplitude will be extracted from the EEG during encoding and maintaining demands. The change between pre and post a single iTBS session will be calculated.
Time frame
Theta-gamma coupling will be obtained immediately before (i.e., pre-iTBS) and after iTBS (i.e., post-iTBS). There will be approximately 5 minutes between the pre and post EEG recordings. The change between pre-iTBS and post-iTBS is the outcome variable.Sponsors and contacts
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Source ClinicalTrials.gov