Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT07478666

Conditions

Functional Neurological Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

This study evaluates whether remotely measured daily activity behavior, captured through a thigh-worn accelerometer, can serve as a reliable and ecologically valid indicator of symptom impact in individuals with Functional Neurologic Disorder (FND). Current clinician-rated assessments capture only a single time point and do not reflect day-to-day symptom variability or functional impact. The study will (1) assess the feasibility of continuous activity monitoring in people with FND, (2) examine associations between activity behavior and established clinician- and patient-reported FND measures, and (3) qualitatively explore participants' lived experiences of daily activity. Findings aim to address a critical gap in understanding real-world function in this heterogeneous population.

Conditions

Functional Neurological Disorder

Study ID

NCT07478666

Start date

Apr 16, 2026

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

Participants with FND:

•Neurologist-confirmed diagnosis of functional neurologic disorder with motor symptoms, sensory symptoms, dizziness, and/or seizures

Healthy Controls:

  • Roughly matched to participants with FND for age and sex
  • Free from major disease that affects mobility (e.g., neurologic, movement, cardiac, pulmonary, renal, and psychiatric disorders) by history.

Exclusion Criteria:

Participants with FND

  • Physical or cognitive symptoms impairing ability to engage with the protocol (e.g., seizure frequency > 10/day).
  • Diagnosis of other major neurologic, cardiovascular, musculoskeletal, or psychiatric disorder that affects mobility as determined by the principal investigator

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

People with FND

Individuals aged 18-65 with neurologist confirmed functional neurological disorder

Healthy Controls

Individuals aged 18-65 who are roughly matched to people with FND for age and sex and free from major disease that affects mobility.

Primary outcome measure

  • Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: enrollment [ Time Frame: 10 Months ]
  • Adherence to thigh-mounted accelerometer use [ Time Frame: From baseline through study completion, an average of 1 week. ]
  • Feasibility of remotely assessed activity behavior with thigh-mounted accelerometry: retainment [ Time Frame: From baseline through study completion, an average of 1 week. ]
  • Acceptability of remotely assessed activity behavior with thigh-mounted accelerometry [ Time Frame: Visit 2 ]

Central Contacts and Locations

Central contacts

Elliot J Gann, DPT

650-282-0897elliot.gann@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Denver, CO, Canada, 80238

Contacts

Elliot J Gann, PT, DPT

6502820897elliot.gann@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • functional neurological disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-18.