Integrated Treatment in FND (Functional Neurological Disorders)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-04

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Functional Neurological Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with FND

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

Group Type EXPERIMENTAL

Psychotherapy

Intervention Type OTHER

The patient will be treated according to Lacanian psychoanalytic ethics, which allows to adequately respond to the patient's request for healing but who at the same time does not ignore the progress of scientific research in the neurological field

Physiotherapy

Intervention Type BEHAVIORAL

Physiotherapy treatment will be articulated through the use of techniques designed to qualify the functionality of the subject divided by symptom: weakness, dystonic attitudes of the limbs, walking disorders, tremor.

Non-Invasive Brain Stimulation (NIBS)

Intervention Type OTHER

Diversified transcranial electrical maneuver protocols with an "on-line" or "off-line" approach may be applied for therapeutic purposes. This will include: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), random noise stimulation (tRNS).

Interventions

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Psychotherapy

The patient will be treated according to Lacanian psychoanalytic ethics, which allows to adequately respond to the patient's request for healing but who at the same time does not ignore the progress of scientific research in the neurological field

Intervention Type OTHER

Physiotherapy

Physiotherapy treatment will be articulated through the use of techniques designed to qualify the functionality of the subject divided by symptom: weakness, dystonic attitudes of the limbs, walking disorders, tremor.

Intervention Type BEHAVIORAL

Non-Invasive Brain Stimulation (NIBS)

Diversified transcranial electrical maneuver protocols with an "on-line" or "off-line" approach may be applied for therapeutic purposes. This will include: transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), random noise stimulation (tRNS).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes