Lexical Access in NeurotypicalsCSSTNCT06870552
Core Semantic Systems TMS
A study testing Single-pulse TMS in people with Lexical Access in Neurotypicals, run by University of South Carolina at 1 site in United States.
Trial summary
This study examines the time course of activation of the left anterior temporal lobe (ATL) during lexical processing using Transcranial Magnetic Stimulation (TMS). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Lexical Access in Neurotypicals
- What is being tested?
- Single-pulse TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants must be within the ages of 18 to 40
- Native speakers of English
Who cannot join
- Potential participants with a clinically reported history of dementia, alcohol abuse, psychiatric or neurological disorders, traumatic brain injury, or extensive vision or hearing problems that prevents them from performing the tasks
- Contraindication to TMS, determined by a standard TMS screening form
- Contraindication to MRI, determined by a standard MRI screening form
- Left handed participants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Prisma Health Richland
Columbia, South Carolina, 29208
Rutvik H Desai, PhD, 803-261-7149, rutvik@sc.edu
Rutvik H Desai, PhD
About this study
Official title: Core Semantic Systems of the Human Brain
This study examines the time course of activation of the left anterior temporal lobe (ATL) during lexical processing using Transcranial Magnetic Stimulation (TMS).
Read the detailed description
This study investigates the activation time of the anterior temporal lobe (ATL) region during lexical processing. Participants will perform three tasks: lexical decision, semantic decision (divided into noun and verb semantic decision), and number judgment.
Lexical Decision Task: Participants will be shown words and pseudowords (e.g., excaid). Participants have to decide if the presented stimulus is a real word or a pseudoword.
Semantic Decision Task: Participants will determine if the stimulus word refers to an action or an object that can be manipulated using the hand or arm.
Half of the stimuli will be nouns, constituting the first semantic decision task with objects, and the other half will be verbs, constituting the second semantic decision task with actions.
Number Judgment Task: Participants will decide if a presented number was divisible by four (e.g., 64) or not (e.g., 69). The stimuli will include numbers with either two or three digits.
For each task, we will collect accuracy and reaction time (RT) data. The primary analyses concern the RTs, but accuracies will also be examined in secondary analyses.
A single pulse TMS will be applied at three different time points: -100 ms, 150 ms, and 400 ms after the onset of the stimulus item. A Magstim BiStim² stimulator with a figure-8 coil will be used. The resting motor threshold (RMT) will be defined as the minimum intensity required to stimulate the motor cortex, eliciting a contraction of the abductor pollicis brevis in at least 5 out of 10 trials. The coil will be positioned at a 45-degree angle along the parasagittal line on the presumed motor cortex area for the APB muscle and adjusted in different directions to find the optimal motor hotspot. Intensity will be between 100% and 120% of resting motor threshold as tolerated by the participant.
The effect of TMS on the response time (RT) at different time points will be examined. TMS will be applied at the left anterior middle temporal gyrus at 10 mm posterior to the tip of the temporal pole. A structural MRI scan will be collected prior to the TMS, which will be used in localizing The target spot. A BrainSight neuronavigation system will be used, with the MRI scan collected before, to localize the target location on the scalp. The tasks will last approximately 30 minutes.
- Conditions
- Lexical Access in Neurotypicals
- Being tested
- Single-pulse TMS
- Keywords
- semantic processing, time course, lexical access, anterior temporal lobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-pulse TMSDevice
A single pulse TMS is delivered at different time points when processing words or numbers.
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Not described Receives: Device: Single-pulse TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reaction time changes in lexical decision from TMS at 150 ms
An interaction between time point (-100, 150) and task (lexical decision, number judgment) RT at the group level (one tailed).
(LD_150 - LD_-100) - (NJ_150 - NJ_-100).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Mean reaction time changes in semantic decision from TMS at 150 ms
An interaction between time point (-100, 150) and task (semantic decision, number judgment) RT at the group level (one tailed).
(SD_150 - SD_-100) - (NJ_150 - NJ_-100).
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start23 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lexical Access in NeurotypicalsStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Rutvik H. Desai, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870552
- Sponsor's protocol ID
- Pro00098791
- Other IDs
- R01DC017162
- Acronym
- CSST
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Semantic Systems of the Human Brain
- ClinicalTrials.gov ID
- NCT06870552
- Acronym / sponsor ID
- CSST / Pro00098791
- Conditions
- Lexical Access in Neurotypicals
- Keywords
- semantic processing, time course, lexical access, anterior temporal lobe
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the time course of activation of the left anterior temporal lobe (ATL) during lexical processing using Transcranial Magnetic Stimulation (TMS).
Detailed description
This study investigates the activation time of the anterior temporal lobe (ATL) region during lexical processing. Participants will perform three tasks: lexical decision, semantic decision (divided into noun and verb semantic decision), and number judgment.
Lexical Decision Task: Participants will be shown words and pseudowords (e.g., excaid). Participants have to decide if the presented stimulus is a real word or a pseudoword.
Semantic Decision Task: Participants will determine if the stimulus word refers to an action or an object that can be manipulated using the hand or arm.
Half of the stimuli will be nouns, constituting the first semantic decision task with objects, and the other half will be verbs, constituting the second semantic decision task with actions.
Number Judgment Task: Participants will decide if a presented number was divisible by four (e.g., 64) or not (e.g., 69). The stimuli will include numbers with either two or three digits.
For each task, we will collect accuracy and reaction time (RT) data. The primary analyses concern the RTs, but accuracies will also be examined in secondary analyses.
A single pulse TMS will be applied at three different time points: -100 ms, 150 ms, and 400 ms after the onset of the stimulus item. A Magstim BiStim² stimulator with a figure-8 coil will be used. The resting motor threshold (RMT) will be defined as the minimum intensity required to stimulate the motor cortex, eliciting a contraction of the abductor pollicis brevis in at least 5 out of 10 trials. The coil will be positioned at a 45-degree angle along the parasagittal line on the presumed motor cortex area for the APB muscle and adjusted in different directions to find the optimal motor hotspot. Intensity will be between 100% and 120% of resting motor threshold as tolerated by the participant.
The effect of TMS on the response time (RT) at different time points will be examined. TMS will be applied at the left anterior middle temporal gyrus at 10 mm posterior to the tip of the temporal pole. A structural MRI scan will be collected prior to the TMS, which will be used in localizing The target spot. A BrainSight neuronavigation system will be used, with the MRI scan collected before, to localize the target location on the scalp. The tasks will last approximately 30 minutes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: Single-pulse TMS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be within the ages of 18 to 40
- Native speakers of English
Key exclusion criteria (4 listed)
- Potential participants with a clinically reported history of dementia, alcohol abuse, psychiatric or neurological disorders, traumatic brain injury, or extensive vision or hearing problems that prevents them from performing the tasks
- Contraindication to TMS, determined by a standard TMS screening form
- Contraindication to MRI, determined by a standard MRI screening form
- Left handed participants
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 |
|---|---|---|
| Single-pulse TMSA single pulse TMS is delivered at different time points when processing words or numbers. | Device | TMS |
Primary outcome
Mean reaction time changes in lexical decision from TMS at 150 ms
Time frame: Through study completion, an average of 1 year.
An interaction between time point (-100, 150) and task (lexical decision, number judgment) RT at the group level (one tailed). (LD_150 - LD_-100) - (NJ_150 - NJ_-100).
1 secondary outcome
Mean reaction time changes in semantic decision from TMS at 150 ms
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-pulse TMS in people with Lexical Access in Neurotypicals, run by University of South Carolina 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rutvik H Desai, PhD (8032617149, rutvik@sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reaction time changes in lexical decision from TMS at 150 ms (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.