NCT07588282

Brief Summary

Functional neurological movement disorders are common conditions that can lead to significant limitations in daily life. They result from a functional disorder in the brain. A clear, understandable, and empathetic explanation of the diagnosis is a crucial first step in treatment. The purpose of this clinical study is to investigate how a clear and detailed explanation of the diagnosis of functional neurological movement disorders affects patients' understanding of their condition and their symptoms The investigators are interested in how well patients understand the diagnosis and the symptoms they experience as the disease progresses, as well as how the conversation between patient and doctor is experienced from both perspectives. In addition, as part of the study, a one-time examination using brain imaging (magnetic resonance imaging) will be conducted to better understand possible differences in brain function.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
19mo left

Started Mar 2026

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

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Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Dec 2027

Study Start

First participant enrolled

March 31, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 14, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

May 5, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Illness Perception

    Revised Illness Perception Questionnaire (IPQ-R), Range (min, max scores) varies by subscale (typically 1-5 per item), Higher scores indicate more negative perceptions.

    4 months (at each measurement point)

  • Trust in the diagnosis

    3 questions whether participants trust the diagnosis

    From immediately post-intervention to the last follow up

  • Doctor shopping intentions

    Question on whether participants intent to consult other physicians regarding their diagnosis in the future

    From post-intervention to the last follow up

  • Symptom Burden of functional movement disorders

    Symptom-Functional Movement Disorder Rating Scale (S-FMDRS), Range: 0 - 60; higher scores mean greater symptom burden and severity

    at baseline and the pre-intervention

  • Patient Global Impression of Severity / Change (PGI-S/C)

    standardized instrument to assess the subjective impression of disease severity and change with 3 items, rated on a likert scale from 1-5. Range of the full scale: 3-15 (higher values indicate higher severity of the disease)

    At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)

  • Clinician Global Impression of Severity / Change (CGI-S/C)

    standardized instrument for clinicians to assess the clinicians' impression of disease severity and change of the patient, with 3 items, rated on a likert scale from 1-5. Range of the full scale: 3-15 (higher values indicate higher severity of the disease)

    At baseline (severity), before the intervention (change), at the first follow up and at the second follow up)

Secondary Outcomes (7)

  • Functional comorbidities

    at baseline

  • Patient-reported outcome measures of functional neurological disorders

    at baseline, pre-intervention, 1st and 2nd follow up

  • health-related quality of life

    baseline, pre-intervention and at the 1st follow up

  • Remaining questions

    immediately after the intervention and at the first follow up

  • Patient preferences

    immediately after the intervention and at the first follow up

  • +2 more secondary outcomes

Study Arms (1)

Standardized FND Psychoeducation Guideline

EXPERIMENTAL
Behavioral: Psychoeducational communication guide for first-diagnosis of FND

Interventions

The intervention is a structured communication protocol used by physicians to provide a systematic, evidence-based explanation of the diagnosis to patients with Functional Movement Disorders (FMD). The primary goal is to foster a common understanding of the condition, validate the patient's experience, and establish a foundation for active rehabilitation. The psychoeducational session follows a 14-step framework designed to address the clinical, neurological, and psychological dimensions of the disorder

Standardized FND Psychoeducation Guideline

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of any of the following functional movement disorders:
  • Functional paralysis
  • Functional seizures
  • Functional tremor
  • Functional drop attacks
  • Functional dystonia
  • Functional twitching
  • Functional facial symptoms
  • Functional tics
  • Functional parkinsonism

You may not qualify if:

  • The patient is unable to give informed consent.
  • The patient is temporarily unable to give informed consent.
  • The patient does not have sufficiently understand German language to answer the questionnaires (the questionnaires are available only in German).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Following an initial baseline assessment (T0), all participants undergo a four-week waiting period without intervention, which serves as an intra-individual control condition.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 14, 2026

Study Start

March 31, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 14, 2026

Record last verified: 2026-05

Locations