TicsNCT07137442
Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
An observational study of Tics and Functional Tics, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tics, Functional Tics
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 1 Aug 2034
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Three groups with up to 25 subjects in each group. Two groups of patients (18-80 years old) with tics and functional tics, and another group of healthy controls.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
- Inclusion criteria for patients with functional tics or tics
- Diagnosed with functional motor tics or motor tics
- Have no neurological or psychiatric disorders established by history and physical/neurological examination
Who cannot join
- Self-reported consumption of >14 alcoholic drinks/week* for a man and >7 alcoholic drinks/week for a woman
- 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.
Show all 17Show fewer
- 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 Beck Depression Inventory II (BDI-II) score >19, Generalized Anxiety Disorder 7-item scale (GAD-7) 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 tested with Modified Rush Video-Based Tic Rating Scale.
- Low Premonitory Urge for Tics Scale (PUTS) score < 9 (maximum 36) with low willingness for tics (patient groups only, not applicable in healthy volunteers).
- 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.
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
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
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.
Read more
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....
Read the detailed description
Study Description:
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
- Tics, Functional Tics
- Keywords
- Tics, Functional tics, EEG, Blink Reflex, Pre-pulse inhibition
- Medical subject headings
- Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Healthy controls | Participants without tics or other neurological or active psychiatric disorders. | |
| Tics | A tic is a sudden, brief and repetitive motor movement or vocalization that is not rhythmic and involves discrete muscle groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical excitability as determined by beta power at the vertex
To determine that the cortical excitability excitability before functional tics are different from those before other tics.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start29 Oct 2026 (estimated)
- Primary completion1 Aug 2034 (estimated)
- Study completion1 Aug 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TicsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra J Ehrlich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137442
- Sponsor's protocol ID
- 10002309
- Other IDs
- 002309-N
- Status last verified
- 16 Sep 2026
- First submitted
- 19 Aug 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinguishing Tics and Functional Tics Using Clinical Neurophysiological Techniques
- ClinicalTrials.gov ID
- NCT07137442
- Acronym / sponsor ID
- 10002309
- Conditions
- Tics, Functional Tics
- Keywords
- Tics, Functional tics, EEG, Blink Reflex, Pre-pulse inhibition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 29 Oct 2026 (estimated)
- Primary completion
- 1 Aug 2034 (estimated)
- Study completion
- 1 Aug 2034 (estimated)
- First posted
- 22 Aug 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.
Background:
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
Study Description:
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Healthy controls | – | –Participants without tics or other neurological or active psychiatric disorders. |
| Tics | – | –A tic is a sudden, brief and repetitive motor movement or vocalization that is not rhythmic and involves discrete muscle groups. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Three groups with up to 25 subjects in each group. Two groups of patients (18-80 years old) with tics and functional tics, and another group of healthy controls.
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following 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.
Key exclusion criteria (17 listed)
- Self-reported consumption of >14 alcoholic drinks/week* for a man and >7 alcoholic drinks/week for a woman
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cortical excitability as determined by beta power at the vertex
Time frame: 2 days
To determine that the cortical excitability excitability before functional tics are different from those before other tics.
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 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Tics
Recruiting
Teen and Adult Tic TMS Study
Tic Disorder
RecruitingPhase 2
CBIT+TMS R33 Phase
Tics, Tourette Syndrome
Enrolling by invitationObservational study
Neural Correlates of Sensory Phenomena in Tourette Syndrome
Tourette Syndrome, Sensory Disorders
Recruiting
Cognitive-psychophysiological Treatment for Tics in Young People With Tourette's Syndrome With or Without Biofeedback
Tourette Syndrome, Tics
Recruiting
Investigating Changes in Premonitory Urges During Habit Reversal Training for Tics
Tics, Tourette Disorder
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.
Debra J Ehrlich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tics and Functional Tics, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 8 inclusion and 17 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 26 Oct 2026. 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 Zhen Ni, Ph.D. ((301) 435-2175, zhen.ni@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical excitability as determined by beta power at the vertex (time frame: 2 days). 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.