Addressing anxiety-related freezing of gait in Parkinson's patients
'Managing the Mental State' to Tackle Anxiety-related Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Intervention Trial
This study tests a new way to help people with Parkinson's manage anxiety to see if it can reduce episodes of freezing while walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen, Gelderland) |
| Trial ID | NCT06302309 on ClinicalTrials.gov |
What this trial studies
This study investigates personalized strategies aimed at reducing anxiety and stress that contribute to freezing of gait (FOG) in individuals with Parkinson's Disease. It focuses on a non-pharmacological intervention designed to help patients manage their mental state over four sessions. The study will evaluate the effectiveness of this tailored approach in alleviating the impact of anxiety on FOG episodes. Participants will be randomly assigned to receive the intervention or standard care to assess the outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with idiopathic Parkinson's Disease who experience daily freezing of gait related to anxiety.
Not a fit: Patients with severe cognitive impairments or other comorbidities that significantly affect gait may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mobility and quality of life for patients experiencing anxiety-related freezing of gait.
How similar studies have performed: While general interventions like mindfulness have been explored, this specific tailored approach to anxiety-related FOG is novel and has not been systematically evaluated before.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Men/women of age \> 18 years with idiopathic Parkinson's disease, as diagnosed by the UK Brain Bank Criteria; * Presence of daily FOG (as objectified with the new-freezing of gait questionnaire), that is related to anxiety (positive answer to the question: Does FOG occur -or get worse when you are anxious or stressed?); * Using a stable dose of PD medication and stability of DBS settings (if applicable) during the trial. Adjustments of PD medication and DBS settings during the trial are allowed if deemed clinically necessary. * Written informed consent. Exclusion Criteria: * Any comorbidity (i.e. neurological, orthopedic) that significantly impacts gait. * Severe cognitive impairment hampering the ability to comply to the study protocol.
Where this trial is running
Nijmegen, Gelderland
- Department of Rehabilitation Radboudumc — Nijmegen, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jorik Nonnekes, PhD — Radboud University Medical Center (Radboudumc)
- Study coordinator: Gijs Vissers, MSc
- Email: gijs.vissers@radboudumc.nl
- Phone: +31636550666
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.