NCT07137442

Brief 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. 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....

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
100mo left

Started May 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

May 11, 2026

Expected
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2034

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2034

Last Updated

May 6, 2026

Status Verified

March 23, 2026

Enrollment Period

8.2 years

First QC Date

August 19, 2025

Last Update Submit

May 5, 2026

Conditions

Keywords

TicsFunctional ticsEEGBlink ReflexPre-pulse inhibition

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 days

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.
  • \- Diagnosed with functional motor tics or motor tics
  • \- Have no neurological or psychiatric disorders established by history and physical/neurological examination

You may not qualify if:

  • 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.
  • 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).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Tics

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Debra J Ehrlich, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Ni, Ph.D.

CONTACT

Debra J Ehrlich, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 22, 2025

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

August 1, 2034

Study Completion (Estimated)

August 1, 2034

Last Updated

May 6, 2026

Record last verified: 2026-03-23

Locations