Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
NCT ID: NCT07137442
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
75 participants
OBSERVATIONAL
2025-11-13
2034-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Tics are involuntary movements and vocalizations. Some tics are organic: They are related to diagnosed disorders. Sometimes tics have other causes, such as problems with how the brain and body send and receive messages. These are called functional tics. It can be difficult to tell the difference between these 2 types of tics. Doctors need to know more so they can make more accurate diagnoses.
Objective:
To learn more about the difference between functional and organic tics.
Eligibility:
Adults aged 18 to 80 years who have a tic that causes involuntary movements. Healthy volunteers with no tics are also needed.
Design:
Participants will have one 4-hour clinic visit. The visit may be done in 1 or 2 days. Participants will refrain from consuming alcohol or caffeine before the visit. They may have a physical exam.
Participants will wear two types of sensors:
Electromyography (EMG): Adhesive disks with sensors will be attached to the skin above some muscles. These disks will record electricity in the muscles as the participant moves.
Electroencephalography (EEG): Sensors will be placed on the participant s scalp. The sensors may be adhered directly, or the participant may wear an electrode cap. The sensors will detect brain waves.
Participants will rest while seated in a chair. Their involuntary tics will be monitored with the EMG and EEG. Then they will be asked to make movements to mimic their tics. Healthy volunteers will also rest; then they will be asked to perform movements that mimic tics.
Participants will have their blink reflex tested. EMG sensors will be placed on the muscles near the eyes. Electrical pulses will be used to stimulate blinking.
Participants will answer questionnaires about their tics and their health....
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The purpose of the protocol is to explore the physiological difference between patients with tics and functional tics.
Objectives:
Primary Objective: To determine if there are differences in cortical excitability before tics in patients with tics compared to functional tics.
Secondary Objectives: N.A.
Exploratory Objectives: To determine if there are differences in cortical and subcortical excitability before tics in patients with tics compared to functional tics.
Endpoints:
Primary Endpoint: This is a hypothesis-driven study. The primary outcome measure is the beta power of EEG signal before the tics at
the electrode over the vertex.
Secondary Endpoints: N.A.
Other exploratory outcome measures include EEG signal power across different frequency bands and Bereitschaftspotential at various electrodes with different movements. Blink reflex and pre-pulse inhibition will also be measured in patients with tics and functional tics and healthy controls under different conditions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Functional Tics
Individuals with tics as the phenomenology of functional movement disorder. The functional tics convey a condition of tics in which the primary pathophysiological processes are alterations in functioning of brain networks rather than abnormalities of brain structures.
No interventions assigned to this group
Healthy controls
Participants without tics or other neurological or active psychiatric disorders.
No interventions assigned to this group
Tics
A tic is a sudden, brief and repetitive motor movement or vocalization that is not rhythmic and involves discrete muscle groups.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Capacity to provide informed consent (self-consent)
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged 18-80
* Agreement to adhere to Lifestyle Considerations prior to and during the physiological testing visit.
\- Diagnosed with functional motor tics or motor tics
\- Have no neurological or psychiatric disorders established by history and physical/neurological examination
Exclusion Criteria
* Use of prescription drugs and other illicit drugs that may suppress tics such as dopamine blocking agents and antipsychotics during a certain time period prior to the
neurophysiological testing session.\*\*
* Clinically significant abnormal movements on neurological examination except for tics.
* Contraindications to EEG or EMG procedures, including skin lesions at electrode sites or hypersensitivity to electrode materials.
* History of or current brain tumor, stroke, head trauma with loss of consciousness.
* Epilepsy or seizures in the past 12 months.
* Have a Baclofen pump, or have neurostimulators for pain.
* Pregnant women
* Self-reported current major depression or BDI-II score \>19, GAD score \> 9, or any major current psychiatric illness.
* Presence of any metal in the eye or skull area such as a brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye.
* Presence of pacemaker, intracardiac lines, implanted pumps or stimulators.
* Unable to comply with the requirements of the study procedures.
* Vocal tics only.
* Note: 1 standard alcoholic drink is 0.6 ounce (14 grams) of pure alcohol.
* Note: The certain time period depends on different drugs used. Five half-lives will be selected. The drug is considered effectively eliminated from the body after this time period because the concentration of the drug reaches around 3% of the orininal concentration.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Debra J Ehrlich, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
002309-N
Identifier Type: -
Identifier Source: secondary_id
10002309
Identifier Type: -
Identifier Source: org_study_id