Temporal Interference Stimulation for Social Cognition
ConditionHealthy Controls
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorColumbia University
About 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 10 healthy participants without known psychiatric illness X 3 successive doses. Participants may participate in 1-3 doses, yielding a total sample size of 10-30 individuals across doses. 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.
Eligibility criteria
Qualifiers
Male or female
Age 18-55 years
Wechsler Adult Intelligence Scale (WAIS) intelligence quotient (IQ) >70
Competent and willing to sign informed consent.
Disqualifiers
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.
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).
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
Trial design
Treatments tested in this trial
- Transcranial Interference Stimulation (tIS)
- Sham tIS
Treatment groups
10 Participants
are divided into 3 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov