ThalamusNCT06083493

Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation

A study testing LIFUP excitation and LIFUP inhibition in people with Thalamus, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Thalamus
What is being tested?: LIFUP excitation and LIFUP inhibition
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 7 Nov 2023to 13 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Must be right-handed.
Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
Must not be on any medications for any neurological, psychological, or psychiatric conditions.
Must be English speaking.
Must be capable of giving written informed consent.

Who cannot join

Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.
Please note: persons needing eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
History of significant head injury with loss of consciousness.
Learning disability or other developmental disorder.
Medication use for any neurological, psychological, or psychiatric conditions.
Any impairment (sensory or motor loss), activity, or situation that in the judgment of the study coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

The purpose of this study is to evaluate the role that the thalamus (the egg-shaped structure in the middle of your brain) plays in perception using a low-intensity ultrasound pulsation (LIFUP) device. The researchers expect to observe differential changes in the perceptual outcomes based on the LIFUP stimulation of different thalamic areas

Conditions: Thalamus
Being tested: LIFUP excitation, LIFUP inhibition
Keywords: Perception

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIFUP excitationDevice
The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.
LIFUP inhibitionDevice
The experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.

Study groups in NCT06083493
Study group	Role	What they receive
LIFUP excitation	Experimental	The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas. Receives: Device: LIFUP excitation
LIFUP inhibition	Experimental	The study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas. Receives: Device: LIFUP inhibition

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Sensitivity Derived From the Signal Detection Theory (SDT)
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal).
Measured: Up to 60 minutes after intervention
Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant's tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).
Measured: Up to 60 minutes after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Nov 202313 Jun 2024

First posted16 Oct 2023
Study start7 Nov 2023
Primary completion13 May 2024
Study completion13 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ThalamusStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06083493
Sponsor's protocol ID: HUM00240514
Status last verified: Oct 2024
First submitted: 3 Oct 2023
Last updated: 19 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
Recruiting
Focused Ultrasound Stimulation for the Treatment of Chronic Pain
Chronic Pain
Recruiting
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Recruiting
Motor Network Physiology
Parkinson Disease, Essential Tremor

All Thalamus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromodulation of Conscious Perception: Investigating Thalamic Roles Through Ultrasonic Stimulation
ClinicalTrials.gov ID: NCT06083493
Acronym / sponsor ID: HUM00240514
Conditions: Thalamus
Keywords: Perception
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 7 Nov 2023 (actual)
Primary completion: 13 May 2024 (actual)
Study completion: 13 Jun 2024 (actual)
First posted: 16 Oct 2023 (actual)
Results: Posted 19 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
LIFUP excitation	Experimental	Device: LIFUP excitationThe study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.
LIFUP inhibition	Experimental	Device: LIFUP inhibitionThe study will involve the enrollment of 60 participants, who will be randomly assigned to two groups, with each group consisting of 30 participants. The participants will be divided based on the type of transcranial LIFUP they will receive, either excitation or inhibition, targeting four specific thalamic areas.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Must be right-handed.
Must have normal or corrected-to-normal vision (while wearing contact lenses). Please note: persons who need eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
Must not be on any medications for any neurological, psychological, or psychiatric conditions.
Must be English speaking.
Must be capable of giving written informed consent.

Key exclusion criteria (6 listed)

Vision that is not 20/20, or vision that is not corrected to 20/20 while wearing contact lenses.
Please note: persons needing eyeglasses to achieve 20/20 vision cannot be included in this study as eyeglasses cannot be worn during the study visit.
History of significant head injury with loss of consciousness.
Learning disability or other developmental disorder.
Medication use for any neurological, psychological, or psychiatric conditions.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIFUP excitationThe experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-excitation) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.	Device	LIFUP excitation
LIFUP inhibitionThe experimental will consist of a 10-minute baseline period (LIFUP-OFF) followed by four 10-minute sessions of stimulating (LIFUP-ON-inhibition) four thalamic areas. The order of thalamic area stimulation will be counterbalanced across participants and will include the ventral anterior (VA), dorsal anterior (DA), ventral posterior (VP), and dorsal posterior (DP) sections of the thalamus.	Device	LIFUP inhibition

Primary outcome

Change in Sensitivity Derived From the Signal Detection Theory (SDT)
Time frame: Up to 60 minutes after intervention
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Sensitivity measured a participant's ability to differentiate between real and scrambled images on a scale from 0.0 to 1.0, with higher scores indicating better accuracy in detecting a signal when it was present and lower scores indicating more missed signals. A score of 1.0 was perfect sensitivity (i.e., never missing a real signal).
Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)
Time frame: Up to 60 minutes after intervention
SDT was a means of measuring participants' ability to differentiate between information-bearing patterns and random patterns that distract from the information. Perceptual criterion measured a participant's tendency to say "yes" or "no" when the participant was unsure if a signal was present. Perceptual criterion was measured on a scale from -1.0 to 1.0, with a score of 0 indicating no bias towards "yes" or "no". Negative scores meant a bias towards "yes" (more likely to say a signal was present), while positive scores meant a bias towards "no" (more likely to say a signal was absent).

Results and safety

Results posted to the registry on 19 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LIFUP Excitation	30	27
LIFUP Inhibition	30	27

Primary outcome: Change in Sensitivity Derived From the Signal Detection Theory (SDT)

Time frame: Up to 60 minutes after intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	LIFUP Excitation n = 27	LIFUP Inhibition n = 27
Baseline	0.7452 (0.1128)	0.7419 (0.1250)
Following intervention	0.7520 (0.1014)	0.7120 (0.1674)

LIFUP Excitation vs LIFUP Inhibition: p = 0.02, Wilcoxon (Mann-Whitney)

Primary outcome: Change in Perceptual Criterion Derived From the Signal Detection Theory (SDT)

Time frame: Up to 60 minutes after intervention. Mean (Standard Deviation). Unit: units on a scale

Measure	LIFUP Excitation n = 27	LIFUP Inhibition n = 27
Baseline	0.3008 (0.2589)	0.2092 (0.2940)
Following intervention	0.3113 (0.3000)	0.2770 (0.3322)

LIFUP Excitation vs LIFUP Inhibition: p = 0.20, Wilcoxon (Mann-Whitney)

Adverse events

Time frame: Up to 32 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LIFUP Excitation	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30
LIFUP Inhibition	0 of 30 (0%)	3 of 30 (10%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Thalamus

Not yet recruiting
Electrophysiological Dose-Response to Anterior Thalamic Deep Brain Stimulation in Drug-Resistant Focal Epilepsy
Drug Resistant Epilepsy, Focal Epilepsy
Not yet recruiting
High-Intensity Focused Ultrasonic Ablation of the Centromedian Thalamic Nucleus for Treatment of Medically Refractory Generalized Epilepsy in Patients Ages 18 Years to 89 Years
Idiopathic Generalized Epilepsy
Recruiting
Focused Ultrasound Stimulation for the Treatment of Chronic Pain
Chronic Pain
Recruiting
CMN LIFU for Enhanced Glymphatic Clearance in Amyloid-Positive MCI
Alzheimer's Disease (AD), Mild Cognitive Impairment (MCI)
Recruiting
Motor Network Physiology
Parkinson Disease, Essential Tremor

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zirui Huang principal investigator

University of Michigan

Anthony Hudetz principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LIFUP excitation and LIFUP inhibition in people with Thalamus, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sensitivity Derived From the Signal Detection Theory (SDT) (time frame: Up to 60 minutes after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06083493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.