Integrated Treatment in FND (Functional Neurological Disorders)

Neuromed IRCCS

Status: Enrolling

Conditions: Functional Neurological Disorder

Treatments: Other: Psychotherapy; Other: Non-Invasive Brain Stimulation (NIBS); Behavioral: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04310670

FND integrated treatment

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Patients with FND

Experimental group

Description:

Diagnosis of Functional Neurological Disorder of movement clinically established according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria

Treatment:

Other: Non-Invasive Brain Stimulation (NIBS)

Other: Psychotherapy

Behavioral: Physiotherapy