CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
20 Hz rTMSdevice
Likely dose
20 Hz rTMS (frequency specified; individual pulse dose/intensity not detailed in available text)AI-extracted
Key inclusion· 6
  • Age 18–40 years
  • Within 10 years of illness onset (first treatment for psychotic symptoms)
  • MINI-confirmed schizophrenia diagnosis
  • No exacerbation in 4 weeks prior to randomization leading to intensification of psychiatric care
Key exclusion· 10
  • Lifetime history of seizure (excluding febrile or substance-withdrawal seizures)
  • First-degree relative with idiopathic epilepsy or seizure disorder
  • History of significant neurological illness
  • Head trauma with loss of consciousness or post-concussive syndrome

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04309370
NCT04309370N/ACompleted

Interactions of Fronto-Parietal High Frequency Repetitive Transcranial Magnetic Stimulation on Anterior Cingulate Cortex Activation in Schizophrenia

Indiana University·interventional·Posted Mar 16, 2020·Updated Aug 3, 2023

In Brief

A clinical study evaluating 20 Hz rTMS for Schizophrenia. Completed, enrolled 14 participants across 2 sites.

Detailed Summary

This will be a single site pilot study. 20 subjects with EPP (Early Phase Psychosis), defined as medical record documentation of the onset of clinically significant psychotic symptoms within the past 10 years, will be enrolled. Prior to randomization subjects will undergo fMRI (Functional Magnetic Resonance Imaging) during CC (Cognitive Control) task (Stroop Color-Word paradigm) and resting-state paradigms. This baseline scan will also include a high-resolution structural sequence for neuronavigation purposes. Then, on two separate days, each occurring one-week apart, subjects will receive one session of excitatory (20 Hz) (Hertz) rTMS (Repetitive Transcranial Magnetic Stimulation) targeting the LDLPFC (Left Dorsolateral Prefrontal Cortex) and one session targeting the LSPC (Left Superior Parietal Cortex). The order of stimulation sites will be randomized and counter-balanced. Immediately following each session, subjects will undergo repeat fMRI during CC and RS (Resting State) paradigms. Investigators will also examine the effect of rTMS on CC performance.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 16, 2020
Enrollment StartMar 12, 2020
Primary CompletionApr 15, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.3 years ago

Interventions

20 Hz rTMSdevice

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that received FDA clearance for use in treatment resistant major depressive disorder in 2008. rTMS utilizes the application of a repetitively pulsed magnetic field over the scalp to induce an electric field within a discrete area of the cerebral cortex. This electric field results in altered ion flow across the neuronal cellular membrane and ultimately changes in neuronal polarization. rTMS modulates cortical activation depending on the stimulation parameters used. Physiological studies have provided evidence that suggests that high-frequency (HF) rTMS produces an increase in local cortical excitability. Studies have also demonstrated that rTMS may increase or decrease functional connectivity between separate but related cortical structures, utilizing high and low frequency stimulation, respectively.