Clinical trial NCT04310670: Integrated Treatment in FND (Functional Neurological Disorders)
Official title: Role of Integrated Treatment in Patients With Functional Neurological Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Functional Neurological Disorder
Keywords: FND
physiotherapy
psychotherapy
non-invasive brain stimulation
Lead sponsor: Neuromed IRCCS
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The project will investigate the effectiveness of patient-centered integrated treatment.

The correlations between physiotherapy indices, non-invasive brain stimulation, connectivity and psychological support will be analyzed.

Detailed description: At the time of recruitment (T0) a multidimensional evaluation will be performed consisting of clinical, neuropsychological, neurophysiological, MRI, data obtained from peripheral blood sampling (10ml). After completing the program (12 weeks), the effect will be assessed according to objectives (T1). The study will also include a follow-up evaluation after 6 months (T2) and 12 months (T3) from the beginning of the treatment to evaluate the persistence of the beneficial effects after some time.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Diagnosis of Functional Neurological Disorder of movement clinically established according to DSM-5 criteria
* Age between 18 and 65 years (inclusive)
* Ability to participate in the study protocol

Exclusion Criteria:

* Inability to provide written informed consent
* Pregnant women
* In case of use of non-invasive brain stimulation techniques: the subjects must not present any of the contraindications specific to this method (for further specifications see the "Methods" and the "Stimulation Evaluation Questionnaire" attached to this proposal)
* Presence of unstable clinical conditions or infections
* In the case of the use of non-invasive brain stimulation techniques: concomitant use of drugs that can alter the transmission and synaptic plasticity (cannabinoids, L-dopa, antiepileptics, nicotine, baclofen, Selective Serotonin Reuptake Inhibitors (SSRI), botulinum toxin)
* Inability to support physiotherapy or psychotherapy sessions

Primary outcomes:
measure: Changes and improvement in clinical condition
timeFrame: 1-12 months
measure: Changes in quality of life
timeFrame: 1-12 months
measure: Changes in executive functions and attention - step 1
timeFrame: 1-12 months
measure: Changes in executive functions and attention - step 2
timeFrame: 1-12 months
measure: Changes in neuroplasticity
timeFrame: 1-12 months
measure: Evaluation of genetic polymorphisms
timeFrame: 1-12 months
Secondary outcomes:
measure: Changes in behavioral aspects - step 1
timeFrame: 1-12 months
measure: Changes in behavioral aspects - step 2
timeFrame: 1-12 months
measure: Changes in behavioral aspects - step 3
timeFrame: 1-12 months
Other outcomes:
Locations:
city: Pozzilli
country: Italy
facility: I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo
state: Isernia
Study officials:
affiliation: IRCCS Neuromed
name: Diego Centonze
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galli S, Bereau M, Magnin E, Moulin T, Aybek S. Functional movement disorders. Rev Neurol (Paris). 2020 May;176(4):244-251. doi: 10.1016/j.neurol.2019.08.007. Epub 2019 Oct 9.
citation: O'Neal MA, Baslet G. Treatment for Patients With a Functional Neurological Disorder (Conversion Disorder): An Integrated Approach. Am J Psychiatry. 2018 Apr 1;175(4):307-314. doi: 10.1176/appi.ajp.2017.17040450. No abstract available.