University of Wisconsin - Madison
Madison, Wisconsin, 53705, United States
Location status: Recruiting
NCT Number: NCT07219719
The goal of this clinical trial is to find out whether a type of electrical brain stimulation, called temporal interference stimulation, can temporarily change the way different parts of the brain communicate with each other.
Participants will:
* Complete two stimulation phases - overnight and during wakefulness * Undergo two MRIs per study phase
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Phase 1
Madison, Wisconsin, 53705, United States
Location status: Recruiting
This study will evaluate the effectiveness of personalized thalamic temporal interference transcranial electrical stimulation (TI-TES) to modulate thalamocortical activity and connectivity in healthy adults. Using a within-subject, counterbalanced crossover design, participants will complete two stimulation phases: (1) repeated overnight TI-TES or sham stimulation during NREM sleep and (2) repeated during quiet wakefulness. Each phase consists of two sessions. Phases are separated by a ≥4-week washout. Resting-state functional magnetic resonance imaging (fMRI) will be acquired before and after each phase to assess sustained changes in thalamocortical functional connectivity, with high-density EEG providing secondary measures of brain-state-specific oscillatory modulation (sigma/spindles in sleep, alpha in wake).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TI-TES uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TI-TES.
Sham (ramp only) stimulation will briefly ramp up and down at the beginning and end of each stimulation train, without delivering continuous stimulation throughout.
Time frame: Pre- to post-intervention, up to 2 weeks
Resting-state fMRI will be used to assess changes in thalamocortical functional connectivity before and after repeated thalamic TI-TES delivered during NREM sleep and quiet wakefulness.
Time frame: 8 weeks
The magnitude of FC changes between sleep and wake stimulation phases will be evaluated.
Time frame: 8 weeks
The spatial distribution of FC changes between sleep and wake stimulation phases will be evaluated.
Time frame: During and after each overnight stimulation session, up to 1 week
Sigma band power will be measured with high density EEG (hdEEG) during stimulation, and will be analyzed to quantify stimulation-related changes in sigma-band power during NREM sleep.
Time frame: During and after each wake stimulation session, up to 1 week
Alpha band power will be measured with hdEEG during stimulation, and will be analyzed to quantify stimulation-related changes in alpha-band power during quiet wakefulness stimulation.
Time frame: 8 weeks
After the ≥4-week washout, thalamocortical FC will be assessed by resting-state fMRI prior to the second stimulation phase.
Time frame: Pre- to post-intervention, up to 2 weeks
Will be measured using diffusion-weighted imaging (DWI) in each phase.
Time frame: Baseline to 12 weeks
Mood will be scored using Positive and Negative Affect Schedule (PANAS). PANAS is a 20 item questionnaire, each item is rated on a 5-point scale, with 1 = "Very slightly or not at all" and 5 = "Extremely". To score PANAS, sum the scores for the 10 Positive Affect (PA) items and the 10 Negative Affect (NA) items separately on the 5-point scale. Higher scores for PA indicate a greater degree of positive emotion, while higher scores for NA indicate more negative emotion, with both scales ranging from 10 (low affect) to 50 (high affect).
Time frame: Baseline to 12 weeks
BoCA™ evaluates eight cognitive domains using randomized, non-repeating tasks to minimize practice effects. The total maximum score is 30. Higher scores indicate better cognitive performance.
Time frame: Up to 1 week
HdEEG will be analyzed to assess stimulation-related changes in spindle density during NREM sleep.
Time frame: Up to 1 week
HdEEG will be analyzed to assess stimulation-related changes in spindle amplitude during NREM sleep.
Time frame: Up to 1 week
HdEEG will be analyzed to assess stimulation-related changes in spindle duration during NREM sleep.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
Acronym: TITAN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07709494
Healthy Participants, Non-cystic Fibrosis Bronchiectasis
Miami, Florida, United States
View Trial DetailsNCT07700953
Healthy Participants
Wuxi, China
View Trial DetailsNCT07035769
Healthy Participants
Edegem, Belgium
View Trial DetailsNCT06564389
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Anaheim, California, United States
View Trial Details