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Brain Criticality, Oculomotor Control, and Cognitive Effort

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Enrolling

Conditions

Healthy

Treatments

Device: transcranial magnetic stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT06344559
2023001006

Details and patient eligibility

About

The project examines electroencephalography, MRI, and behavioral measures indexing flexibility (critical state dynamics) in the brain when healthy young adults do demanding cognitive tasks, and in response to transcranial magnetic stimulation.

Full description

The healthy human brain is a complex, dynamical system which is hypothesized to operate, at rest, near a phase transition - at the boundary between order and chaos. Proximity to this critical point is functionally adaptive as it affords maximal flexibility, dynamic range, and information transmission capacity, with implications for short term memory and cognitive control. Divergence from this critical point has become correlated with diverse forms of psychopathology and neuropathy suggesting that distance from a critical point is both a potential biomarker of disorder and also a target for intervention in disordered brains. The Investigators have further hypothesized that task performance depends on how closely brains operate to criticality during task performance and also that subjective cognitive effort is a reflection of divergence from criticality, induced by engagement with demanding tasks.

A key control parameter determining distance from criticality in a resting brain is hypothesized to be the balance of cortical excitation to inhibition (the "E/I balance"). Transcranial magnetic stimulation is a widely used experimental and clinical tool for neuromodulation and theta-burst stimulation (TBS) protocols are thought to modulate the E/I balance. Here the Investigators test whether cortical dynamics can be systematically modulated away from the critical point with continuous theta-burst stimulation (cTBS) and intermittent theta-burst stimulation (iTBS), which is thought to decrease and increase E/I balance, respectively. Depending on baseline E/I balance prior to stimulation, this will make people's brains either operate closer to, or farther away from critiality and thereby impact on cognitive control and subjective cognitive effort during performance of control-demanding tasks.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study and availability for the duration of the study
  3. Males and females; Ages 18-45
  4. Healthy, neurologically normal with no diagnosed mental or physical illness
  5. Willingness to adhere to the MRI and two session stimulation protocol
  6. Fluent in English
  7. Normal or corrected to normal vision
  8. At least twelve years of education (high school equivalent)

Exclusion criteria

  1. Ongoing drug or alcohol abuse
  2. Diagnosed psychiatric or mental illness
  3. Currently taking psychoactive medication
  4. Prior brain injury
  5. Metal in body
  6. History of seizures or diagnosis of epilepsy
  7. Claustrophobia
  8. Pregnant or possibly pregnant
  9. Younger than 18 or older than 45
  10. Use of medications which potentially lower the usage threshold

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

60 participants in 3 patient groups

Continuous theta burst stimulation
Active Comparator group
Description:
In a cross-over design, all participants will, in one session, receive continuous theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.
Treatment:
Device: transcranial magnetic stimulation
Intermittent theta burst stimulation
Active Comparator group
Description:
In a cross-over design, all participants will, in one session, receive intermittent theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.
Treatment:
Device: transcranial magnetic stimulation
Sham theta burst stimulation
Sham Comparator group
Description:
In a cross-over design, all participants will, in one session, receive sham theta burst stimulation, to the right frontal eye field. Session order will be counter-balanced across participants, and stimulation protocol will be blinded to participants and the Investigator until after data collection is complete.
Treatment:
Device: transcranial magnetic stimulation

Trial documents
2

Trial contacts and locations

1

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Central trial contact

John A Westbrook, PhD

Data sourced from clinicaltrials.gov

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