Integrated treatment for Functional Neurological Disorders
Role of Integrated Treatment in Patients With Functional Neurological Disorder
This study tests a new combined treatment of therapy, physical exercises, and brain stimulation to see if it helps people with Functional Neurological Disorder feel better over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Neuromed IRCCS Academic / other |
| Locations | 1 site (Pozzilli, Isernia) |
| Trial ID | NCT04310670 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness of a patient-centered integrated treatment approach for Functional Neurological Disorder (FND). It combines physiotherapy, psychotherapy, and non-invasive brain stimulation to assess their collective impact on patients. A multidimensional evaluation will be conducted at the start of the treatment, followed by assessments at 12 weeks, 6 months, and 12 months to evaluate the persistence of benefits. The study aims to analyze correlations between treatment modalities and various clinical and neurophysiological indices.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a clinically established diagnosis of Functional Neurological Disorder of movement.
Not a fit: Patients who are pregnant, unable to provide consent, or have unstable clinical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this integrated treatment could significantly improve the quality of life for patients suffering from Functional Neurological Disorders.
How similar studies have performed: While integrated treatment approaches for FND are emerging, this specific combination of therapies is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pozzilli, Isernia
- I.R.C.C.S. NEUROMED Istituto Neurologico Mediterraneo — Pozzilli, Isernia, Italy (Recruiting)
Study contacts
- Principal investigator: Diego Centonze — IRCCS Neuromed
- Study coordinator: Diego Centonze, MD
- Email: ambulatoriodnf.neuromed@gmail.com
- Phone: +390865929250
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.