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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Transcranial Interference Stimulation (tIS)
DeviceField strength dose of 0.30 - 0.40 V/m
Sham tIS
Other interventionSham transcranial interferential stimulation. Sham comparator to be administered to all groups.
Treatment groups
10 Participants
are divided into 3 treatment groupsGroup A: Active tIS 0.30 V/m and ShamActive comparator 2 interventions
Group B: Active tIS 0.35 V/m and ShamActive comparator 2 interventions
Group C: Active tIS 0.40 V/m and ShamActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pulvinar nucleus (PuN) activation levels
Pulvinar nucleus (PuN) activation levels as determined by functional magnetic resonance imaging (fMRI, safety) These analyses assess the degree to which presentation of a stimulus designed to activate the pulvinar nucleus leads to an increase in local activation as reflected in the fMRI response. Units will be % increase in signal strength during stimulation vs. baseline.
Time frame
Once at baseline (day 1) and twice during each phase (day 8, day 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants2
Amplitude of 10-Hz visual Steady-State Response (ssVEP)
(Target engagement) This measure is obtained simultaneously with tIS and reflects the response of visual cortex to repetitive stimulation. Response is measured in microvolt-squared (uV2).
Time frame
Twice during each phase (day 8, day 15): 1x during active stimulation, 1x during sham stimulation in randomized order across participantsSecondary outcomes
1
Brunoni safety scale
The Brunoni scale is a self-report scale for potential side effects following tIS, including headache, neck pain, scalp pain, tingling, itching, burning sensation, skin redness, sleepiness, trouble concentrating, acute mood change and "other"; Scores range from 1 (no discomfort) to 5 (severe discomfort). HIgher scores indicate greater severity.
Time frame
Following each tIS session (day 8, 15)2
Wong-Baker safety scale
The Wong-Baker uses emotion faces to allow individuals to indicate the level of discomfort associated with the procedure. Scores range from 1 (no discomfort) to 5 (severe discomfort). Higher scores indicate greater discomfort.
Time frame
Following each tIS session (day 8, 15)3
Pulvinar nucleus (PuN) tissue levels of N-acetyl aspartate (NAA)
PuN tissue level of N-acetyl-aspartate (NAA)as determined by MRS (safety) NAA is a potential measure of oxidative stress. NAA levels will be measured as the amplitude of the NAA peak of the MRS spectrum.
Time frame
Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participants4
Pulvinar nucleus (PuN) tissue levels of glutathione (GSH)
PuN tissue levels of glutathione (GSH), as determined by MRS (safety) GSH is a potential measure of oxidative stress. It will be defined based on the amplitude of the GSH peak in the MRS spectrum.
Time frame
Once at baseline (day 1) and twice during each phase (day 8, 15): 1x following active stimulation, 1x following sham stimulation in randomized order across participantsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov