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Functional Neurological DisorderNCT05634486

Efficacy of the Multidisciplinary Treatment to the Quality of Life of With Functional Movement Disorders

A study testing Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy) in people with Functional Neurological Disorder and Functional Movement Disorder, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSpain
Study dates
15 Jun 2022to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Functional Movement Disorders (Espay and Lang, 2015)
  • Patients should be 18 years old or older and capable of giving consent to freely and willingly participate in the study.
  • Patients should be able to attend the one-month ambulatory regime and follow-up visits.

Who cannot join

  • Any condition that avoid the patient from giving free consent to participate in the study.
  • Any non-controlled psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Virgen del Rocío / Instituto de Biomedicina de Sevilla (IBiS)

    Seville, 41013

Other trials in Spain

About this study

Official title: Efficacy Study of the Multidisciplinary Therapeutic Approach to the Quality of Life of Patients With Functional Movement Disorders and Their Caregivers

Randomized-clinical trial of multidisciplinary approach versus psychoeducation in patients with functional movement disorders: impact to their quality of life and their caregivers' quality of life. Patients with functional movement disorders are randomized in two arms of a one-month treatment (physiotherapy + cognitive-behavioral therapy versus psychoeducational as sham intervention) with a 3-month and 5-month follow-up where the investigators will measure the change in the patients' and caregivers' quality of life. Movement disorders specialists will review the severity of symptoms as blinded raters in the 3th-month and 5th-month follow-up.

Being tested
Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy), Psychoeducation (Sham intervention)
Medical subject headings
Conversion Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)Behavioural

    Patients randomly allocated to this arm of intervention will receive an ambulatory therapy regime of twelve 60-minute physiotherapy sessions plus four 60-minute psychotherapy sessions throughout one month of treatment

  • Psychoeducation (Sham intervention)Other

    Patients randomly allocated to this arm of intervention will receive an ambulatory regime of four 60-minute non-organized psychoeducational sessions throughout one month of treatment.

Study groups in NCT05634486
Study groupRoleWhat they receive
Multidisciplinary therapeutic approachExperimental* Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist). * 12 physiotherapy sessions during one month (three 60-minute sessions per week) administered by a physiotherapist with experience in functional neurological disorders. * 4 cognitive-behavioral therapy sessions during one month (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
Receives: Behavioral: Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy)
PsychoeducationSham comparator* Diagnosis of Functional Movement Disorders by one of the PI (Movement Disorders Specialist). * 4 psychoeducational sessions (one 60-minute intervention per week) administered by a psychologist with experience in cognitive-behavioral therapy.
Receives: Other: Psychoeducation (Sham intervention)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale

    Change in the patients' quality of life measured by changes in EQ-5D-5L - the EQ visual analogue scale (EQ VAS).

    Measured: 3th-month and 5th-month follow-ups

  2. Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ-5D descriptive system.

    Change in the patients' quality of life measured by changes in EQ-5D-5L - EQ-5D descriptive system. The digits for the five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) can be combined into a 5-digit number that describes the patient's health state.

    Measured: 3th-month and 5th-month follow-ups

  3. Quality of Life in patients with functional movement disorders measured by the 36-Item Short Form Health Survey (SF-36)

    Change in the patients' quality of life measured by changes in SF-36

    Measured: 3th-month and 5th-month follow-ups

Secondary outcomes (4)

  1. Quality of Life in caregivers of patients with functional movement disorders

    Change in the caregivers' quality of life measured by changes in the Zarit Caregiver Burden Interview

    Measured: 3th-month and 5th-month follow-ups

  2. Severity of functional neurological symptoms of patients with functional movement disorders measured by Clinical Global Impressions (CGI) Scale

    Change in the patients' symptoms severity measured by changes in the Clinical Global Impressions (CGI) Scale - Severity

    Measured: 3th-month and 5th-month follow-ups

  3. Improvement of functional neurological symptoms of patients with functional movement disorders

    Improvement of the patients' symptoms severity measured by the Clinical Global Impressions (CGI) Scale - Improvement

    Measured: 3th-month and 5th-month follow-ups

  4. Severity of functional neurological symptoms of patients with functional movement disorders

    Change in the patients' symptoms severity measured by changes in the simplified-Functional Movement Disorders Rating Scale

    Measured: 3th-month and 5th-month follow-ups

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2022
  2. Study start15 Jun 2022
  3. Primary completion31 Aug 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
40 patients with functional movement disorders will be randomized into two arms of treatments: a one-month multidisciplinary treatment (physiotherapy + cognitive-behavioral therapy) versus a one-month psychoeducation sham intervention (control group).
Masking
Single blind
Who is masked
Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05634486
Sponsor's protocol ID
1633-N-21
Status last verified
Feb 2024
First submitted
21 Nov 2022
Last updated
22 Feb 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Macias-Garcia D, Mendez-Del Barrio M, Canal-Rivero M, Munoz-Delgado L, Adarmes-Gomez A, Jesus S, Ojeda-Lepe E, Carrillo-Garcia F, Palomar FJ, Gomez-Campos FJ, Martin-Rodriguez JF, Crespo-Facorro B, Ruiz-Veguilla M, Mir P. Combined Physiotherapy and Cognitive Behavioral Therapy for Functional Movement Disorders: A Randomized Clinical Trial. JAMA Neurol. 2024 Sep 1;81(9):966-976. doi: 10.1001/jamaneurol.2024.2393.

    PubMed 39102249

Questions about this trial

What is this clinical trial studying?

A study testing Multidisciplinary therapeutic approach (physiotherapy plus cognitive-behavioral therapy) in people with Functional Neurological Disorder and Functional Movement Disorder, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 22 Feb 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life in patients with functional movement disorders measured by The 5-level EQ-5D version (EQ-5D-5L) - EQ visual analogue scale (time frame: 3th-month and 5th-month follow-ups). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05634486, which also lists 1 linked publication.

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 22 Feb 2024.

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