INTEGRATED TREATMENT IN FND (Functional Neurological Disorders)

Sponsor

Neuromed IRCCS (Other)

Overall Status

Unknown status

CT.gov ID

NCT04310670

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

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 1.1, 1.2, 1.3, 1.4 (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.

Condition or Disease	Intervention/Treatment	Phase
Functional Neurological Disorder	Behavioral: Psychotherapy, Physiotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

ROLE OF INTEGRATED TREATMENT IN PATIENTS WITH FUNCTIONAL NEUROLOGICAL DISORDER

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with FND Diagnosis of Functional Neurological Disorder of movement clinically established according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria	Behavioral: Psychotherapy, Physiotherapy The 12-week program aims to improve patients' motor symptoms, gain insight into disease mechanisms, regain control over abnormal movements, and learn better coping strategies. All members of the therapy team will be consistent in planning communication and treatment goals. 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. From a psychological point of view, 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. Furthermore, diversified transcranial electrical stimulation protocols may be applied for therapeutic purposes. Other Names: transcranial electrical stimulation

Arm

Intervention/Treatment

Experimental: Patients with FND

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

Behavioral: Psychotherapy, Physiotherapy

The 12-week program aims to improve patients' motor symptoms, gain insight into disease mechanisms, regain control over abnormal movements, and learn better coping strategies. All members of the therapy team will be consistent in planning communication and treatment goals. 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. From a psychological point of view, 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. Furthermore, diversified transcranial electrical stimulation protocols may be applied for therapeutic purposes.

Other Names:

transcranial electrical stimulation

Outcome Measures

Primary Outcome Measures

Changes and improvement in clinical condition [baseline and after 3,6,12,24 months]
Clinical global impression
Changes in quality of life [baseline and after 3,6,12,24 months]
Sf-36
Changes in physical activity [baseline and after 3,6,12,24 months]
International Physical Activity Questionnaire
Changes in executive functions and attention - step 1 [baseline and after 12,24 months]
Symbol Digit Modalities Test
Changes in executive functions and attention - step 2 [baseline and after 12,24 months]
Stroop test
Changes in neuroplasticity [baseline and after 6,12,24 months]
Transcranial Magnetic Stimulation (TMS) will be used to evaluate the change of neuronal plasticity in a subgroup of patients who will not present contraindications to the method. The TMS uses short-lived magnetic fields and high intensity applied at the scalp level to activate the neurons of a small region of the cerebral cortex through an electromagnetic induction. When these impulses are applied repeatedly, it is possible to induce plastic modification of cortical excitability. Any increase or decrease in amplitude, which persists after the end of TMS repetitive stimulation, indicates that there have been changes in the cortical, long term potentiation (LTP) or depression (LTD).
Evaluation of genetic polymorphisms [baseline]
A blood sample (10 ml) will be collected to investigate whether genetic polymorphisms related to patients' neuronal plasticity can be related to the response to the protocol.

Secondary Outcome Measures

Changes in psychosomatic aspects [baseline and after 3,6,12,24 months]
Fenorabia Psychosomatic Inventory
Changes in physical effects of the interventions [baseline and after 3,6,12,24 months]
Visual Analogue Scale
Changes in psychosocial effects of the interventions [baseline and after 3,6,12,24 months]
Paradise 24
Changes in psychological well-being [baseline and after 3,6,12,24 months]
Psychological Well-Being Scale
Changes in behavioral aspects [baseline and after 3,6,12,24 months]
STAI-Y

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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