Transcranial Interference Stimulation for Social Cognition

(TISSC Trial)

Overseen By Pejman Sehatpour, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Daniel C Javitt, M.D., Ph.D.

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for healthy individuals without any known psychiatric conditions. It's a preliminary study to test the safety of a new procedure called transcranial interference stimulation (tIS), which might be used in the future to treat severe neuropsychiatric disorders.

Inclusion Criteria

I am either male or female.

Wechsler Adult Intelligence Scale (WAIS) intelligence quotient (IQ) >70

I am able and willing to sign the consent form.

Exclusion Criteria

Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)

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)

I have a history of significant illnesses like heart issues or abnormal EKGs.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Initial MRI session to localize the pulvinar nucleus of the thalamus and assess baseline levels

1 week

1 visit (in-person)

Treatment

Participants receive transcranial interference stimulation (tIS) with dose escalation and sham interventions

3 weeks

Multiple visits (in-person) for tIS and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Temporal Interference Stimulation

Trial Overview The trial is testing tIS, where electrical currents are applied to the brain, against Sham tIS, which mimics the treatment but doesn't actually deliver currents. Participants will undergo brain scans and other tests to see how they respond.

Participant Groups

Group I: Active tIS 0.30 V/m and Sham Active Control 2 Interventions

Group 1 with 10 participants to receive a dose of 0.30 V/m and sham. The order of the intervention will be randomized.

Group II: Active tIS 0.35 V/m and Sham Active Control 2 Interventions

Group 2 with 10 participants to receive a dose of 0.35 V/m and sham. The order of the intervention will be randomized.

Group III: Active tIS 0.40 V/m and Sham Active Control 2 Interventions

Group 3 with 10 participants to receive a dose of 0.40 V/m and sham. The order of the intervention will be randomized.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+