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Temporal Interference Stimulation for Social Cognition

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Healthy ControlsTranscranial Interference Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The long-term goal of this project is to evaluate whether a procedure termed transcranial interference stimulation (tIS) may be useful in the future in the treatment of severe neuropsychiatric disorders such as schizophrenia. The purpose of this stage of the project is to evaluate the safety and tolerability of tIS administration in healthy volunteers. This study involves 30 healthy participants without known psychiatric illness, who will participate in groups of 10. The dose of tIS will be escalated progressively across doses. Functional magnetic resonance imaging (fMRI), magnetic resonance spectroscopy (MRS) and side effect checklists will be used to assess tIS safety/tolerability at each dose. In addition, electroencephalogram (EEG) will be collected simultaneously with tIS and used to assess target engagement. Face emotion recognition (FER) data will also be collected, but will be used for feasibility assessment only. If successful, these studies will form the basis for future studies in schizophrenia.

Official Title

Use of Alpha-frequency Deep Transcranial Interference Stimulation (tIS) to Understand and Modify Temporal Dynamics of Face Emotion Recognition and Social/Affective Function

Quick Facts

Study Start:2025-03-03
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06607432

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female
  2. * Age 18-55 years
  3. * Wechsler Adult Intelligence Scale (WAIS) intelligence quotient (IQ) \>70
  4. * Competent and willing to sign informed consent.
  5. * Shall not have been prescribed any standing medications for treatment of a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Axis I psychiatric disorders within 90 days of the study and shall not have been prescribed standing opioid analgesic, anticonvulsant, antidementia, antidepressant, antimigraine, antipsychotic, anxiolytic, bipolar agents, central nervous system agents, or sedative/hypnotics within 90 days of the study even if for a non-psychiatric indication. Intermittent use of sedative/hypnotic medications is permitted, but these agents shall not be used within 48 hours of the tIS administration.
  6. * Healthy relative to age-dependent expectation as determined by medical history and physical examination within 90 days of enrollment.
  1. * Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator (PI), may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results.
  2. * Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
  3. * On the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version-Recent, answers YES to Question 3 and NO to Question 6 (Moderate Risk) or answers YES to Question 4, 5, or 6 (High Risk).
  4. * Presence or positive history of significant medical illnesses, including high blood pressure(defined as systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP) \>90, low blood pressure (SBP \<100, DBP \<60), orthostatic blood pressure as baseline (change in mean arterial pressure \[1/3 systolic + 2/3 diastolic\] of \>20%), cardiac illness, or clinical significant abnormal electrocardiogram (EKG), as determined by the site physician
  5. * Women of childbearing potential who, at enrollment or during the study:
  6. * have a positive urine pregnancy test or a self-reported pregnancy;
  7. * are heterosexually active without usage of a medically acceptable, highly effective contraceptive method\* ( 1% pregnancy rate); or
  8. * are planning to become pregnant during the course of this study, as determined by the PI, are excluded from study participation. Examples include tubal ligation, vasectomized partner, intrauterine device (IUD) or intrauterine system (IUS), and longacting reversible contraceptives (LARC).

Contacts and Locations

Study Contact

Daniel C Javitt, M.D., Ph.D.
CONTACT
1 6467745404
dcj2113@cumc.columbia.edu
Pejman Sehatpour, Ph.D.
CONTACT
1 6467745236
ps2723@cumc.columbia.edu

Principal Investigator

Daniel C Javitt, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Daniel C Javitt, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2026-10-30

Terms related to this study

Keywords Provided by Researchers

  • Transcranial Interference Stimulation

Additional Relevant MeSH Terms

  • Healthy Controls