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Integrated Treatment in FND (Functional Neurological Disorders)

N

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

Trial contacts and locations

1

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Central trial contact

Mario Stampanoni Bassi, MD; Diego Centonze, MD

Data sourced from clinicaltrials.gov

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