Integrated Treatment in FND (Functional Neurological Disorders)

NCT04310670 | Recruiting

• 1 other identifier: FND integrated treatment
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neurological Disorder

Keywords

FND; physiotherapy; psychotherapy; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Changes in behavioral aspects - step 1

  1-12 months

• Changes in behavioral aspects - step 2

  1-12 months

• Changes in behavioral aspects - step 3

  1-12 months

Study Arms (1)

Patients with FND

EXPERIMENTAL

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

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

Interventions

Psychotherapy 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

Patients with FND

Physiotherapy 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.

Patients with FND

Non-Invasive Brain Stimulation (NIBS) 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).

Patients with FND

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo

Pozzilli, Isernia, 86077, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 31606137 RESULT

• 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.

  PMID: 29606068 RESULT

MeSH Terms

Conditions

Conversion Disorder

Interventions

Psychotherapy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Therapeutics; Rehabilitation

Study Officials

• Diego Centonze

  IRCCS Neuromed

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diego Centonze, MD

CONTACT

+390865929250; ambulatoriodnf.neuromed@gmail.com

Mario Stampanoni Bassi, MD

CONTACT

+39 3460181370; mario_sb@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 17, 2020
• Study Start: September 4, 2020
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

IT (1)