Integrated Treatment in FND (Functional Neurological Disorders) (FND)

Role of Integrated Treatment in Patients With Functional Neurological Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Functional Neurological Disorder
• Intervention / Treatment: Other: Psychotherapy; Behavioral: Physiotherapy; Other: Non-Invasive Brain Stimulation (NIBS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diego Centonze, MD; Phone Number: +390865929250; Email: ambulatoriodnf.neuromed@gmail.com
• Study Contact Backup: Name: Mario Stampanoni Bassi, MD; Phone Number: +39 3460181370; Email: mario_sb@hotmail.it

Study Locations

• Italy
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Recruiting
      • I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

Other: 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; Behavioral: 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.; Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes and improvement in clinical condition	the Clinical global impression scale will be used. It is a brief 3-item observer-rated scale that assess severity of illness with assignable scores ranging from 0 to 7 (at every time time point), the global improvement with assignable scores ranging from 0 to 7 (from the second time point), and the efficacy index with assignable scores ranging from 1 to 16 (relationship between therapeutic efficacy and undesirable effects). Higher scores on these scales mean a worse outcome.	1-12 months
Changes in quality of life	The Short Form Health Survey 36 (SF-36) will be used. It is a generic, multidimensional tool, consisting of 36 questions that can be divided into 8 scales (Physical functioning, limitations due to physical health, limitations due to emotional problems, energy and fatigue, emotional well-being, social activities, pain, general health perception) expressed as percentage values 0-100%. Higher scores on these scales mean a better quality of life.	1-12 months
Changes in executive functions and attention - step 1	Will be used the Symbol Digit Modalities Test, which measures the processing speed, in the oral version of this test (Nocentini et al., 2006). The assignable performance's scores ranging from 0 to 110. The cut-off for normality in italian population for this oral version was 34.2. Higher scores on these scales mean a better processing speed.	1-12 months
Changes in executive functions and attention - step 2	Stroop test	1-12 months
Changes in neuroplasticity	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).	1-12 months
Evaluation of genetic polymorphisms	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.	1-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in behavioral aspects - step 1	State-Trait Anxiety Inventory-Form Y (STAI-Y). The STAI-Y is a self-report questionnaire consisting of two 20-item scales providing separate measures of state and trait anxiety, on a 4-point Likert scale, with scores ranges from 20 to 80, with higher scores indicating more severe outcome.	1-12 months
Changes in behavioral aspects - step 2	Beck Depression Inventory - Second Edition (BDI-II). BDI-II is a self-report questionnaire consisting of 21-item self-report scale designed to measure the severity of depressive symptoms, on a 4-point Likert scale, with scores ranges from 0 to 63, with higher scores indicating more severe outcome.	1-12 months
Changes in behavioral aspects - step 3	Toronto Alexithymia Scale (TAS-20). TAS-20 is a self-report questionnaire scale designed to measure alexithymia, on a 5-point Likert scale, with scores ranges from 20 to 100, with higher scores indicating more severe outcome.	1-12 months

Collaborators and Investigators

• Sponsor: Neuromed IRCCS
• Investigators: Principal Investigator: Diego Centonze, IRCCS Neuromed

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 13, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: psychotherapy; physiotherapy; non-invasive brain stimulation; FND
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Somatoform Disorders; Histrionic Personality Disorder; Nervous System Diseases; Conversion Disorder; Hysteria
• Other Study ID Numbers: FND integrated treatment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No