Transcranial Interference Stimulation for Social Cognition

(TISSC Trial)

Overseen By Christoph Juchem, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Opioids, Anticonvulsants, Antidepressants, others

Disqualifiers: Hypertension, Cardiac illness, Pregnancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a procedure called transcranial interference stimulation (tIS) to determine its safety and ease of use. The researchers aim to discover if tIS could potentially treat serious mental health issues like schizophrenia. Healthy individuals will participate, grouped into sets of 10, and will receive varying doses of the tIS treatment (also known as Temporal Interference Stimulation) alongside a placebo. Ideal participants are healthy adults without psychiatric conditions or ongoing mental health treatments. As an unphased trial, this study allows participants to contribute to groundbreaking research that could shape future mental health treatments.

Will I have to stop taking my current medications?

Yes, you must not have been prescribed any medications for psychiatric disorders or certain other medications like opioids, anticonvulsants, or antidepressants within 90 days before the study. Intermittent use of sedatives is allowed, but not within 48 hours of the procedure.

What prior data suggests that transcranial interference stimulation is safe?

Research has shown that temporal interference stimulation (tIS) is generally safe and well-tolerated. Studies have found that tIS can be used without causing major side effects. For instance, one study demonstrated that tIS could safely target brain areas like the hippocampus without harm. Another study tested higher levels of stimulation and found it remained safe and effective.

Participants in these studies reported only mild effects, such as slight tingling or discomfort at the stimulation site. The absence of serious side effects in these trials is encouraging for the safety of tIS. Ongoing research aims to confirm that tIS remains a safe option for future treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Temporal Interference Stimulation (tIS) for social cognition because it offers a novel approach to brain stimulation. Unlike traditional methods that directly target the brain's surface, tIS uses intersecting electrical fields to stimulate deeper brain regions non-invasively. This technique could potentially enhance social cognition without the risks associated with more invasive procedures. The innovation of tIS lies in its ability to precisely target complex brain networks involved in social processing, which might lead to more effective and safer interventions compared to current options.

What evidence suggests that transcranial interference stimulation is effective for social cognition?

Research has shown that temporal interference stimulation (tIS) can enhance brain functions like memory by increasing efficiency. Studies have found that tIS can safely reach deep brain areas and alter brain cell communication. Evidence suggests that tIS might aid in severe mental health issues, such as schizophrenia, by targeting specific brain regions. Early results indicate it could improve symptoms like lack of motivation when certain brain areas are stimulated. In this trial, participants will receive different doses of tIS—specifically 0.30 V/m, 0.35 V/m, or 0.40 V/m—alongside sham treatments. Overall, tIS appears promising for adjusting brain functions and may help treat psychiatric disorders in the future. ^{2 3 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

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

I am healthy for my age, as confirmed by a recent medical check-up.

I am either male or female.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06607432?term=brunoni&viewType=Table&rank=2

Temporal Interference Stimulation for Social Cognition 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11815565/

Temporal Interference Stimulation Boosts Working Memory ... Overall, our findings suggest that TI stimulation may enhance cognitive efficiency, enabling better behavioral performance with reduced ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.03.31.25324806v2.full.pdf

Efficacy and Safety of Transcranial Temporal Interference ... Despite the limited sample size, our preliminary findings demonstrated that 130Hz TIS targeting right NAc could improve both negative symptoms ...

4. nature.com nature.com/articles/s41593-023-01456-8

Non-invasive temporal interference electrical stimulation of ... We demonstrate the safety and tolerability of TI stimulation in humans, the ability to focally target the stimulation locus to the hippocampus, ...

5. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1536906/full

Advances in the application of temporal interference ... Conclusion: TIS can effectively penetrate the cerebral cortex and modulate neural activity in deep brain regions. Additionally, TIS shows potential for treating ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496688/

Safety Evaluation of Employing Temporal Interference ... Safety evaluation of employing temporal interference transcranial alternating current stimulation in human studies.

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2024.1484593/full

The safety and efficacy of applying a high-current temporal ... This study aimed to introduce a high-current TI electrical stimulation protocol to enhance its intensity and evaluate its safety and efficacy

8. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-07158-8

Individualized transcranial temporal interference stimulation ... This study aims to evaluate the safety and efficacy of tTIS targeting the right nucleus accumbens (NAc) in ameliorating cognitive deficits and negative ...