Tackling Anxiety-related Freezing of Gait in People With Parkinson's Disease

Freezing of Gait Clinical Trial

— TACKLING-FOG  

Official title:

'Managing the Mental State' to Tackle Anxiety-related Freezing of Gait in People With Parkinson's Disease: a Randomized Controlled Intervention Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06302309
• Other study ID #: NL85217.091.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: September 2025

Study information

• Verified date: March 2024
• Source: Radboud University Medical Center
• Contact: Gijs Vissers, MSc
• Phone: +31636550666
• Email: gijs.vissers[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether personalized strategies that target anxiety and stress surrounding freezing of gait can alleviate freezing of gait in people with Parkinson's Disease.

Description:

Rationale:

Freezing of Gait (FOG) is a common and disabling symptom in people with Parkinson's Disease (PD), characterized by paroxysmal episodes where there is an inability to step effectively, despite attempting to do so. Treatment consists of complementary pharmacological and non-pharmacological treatment options which unfortunately only partially alleviate FOG. Anxiety has been found to contribute to the occurrence and exacerbation of FOG, which often manifests itself in situations where people with FOG anticipate not being in control of their movements. People with FOG are often aware of the feelings and situations that elicit FOG episodes, but they rarely actively employ strategies targeting their mental state to improve FOG. With the exception of general interventions including mindfulness, yoga and meditation, tailored strategies to ameliorate anxiety-related FOG have never been evaluated in a systematic manner.

Objective:

In this project we aim to evaluate whether a non-pharmacological and tailored intervention targeting anxiety- and stress-related FOG in people with PD is effective to reduce the impact of anxiety and stress on FOG. Specifically, we aim to study: (1) the effect of four sessions of a 'managing the mental state' intervention in people with disabling and anxiety-related FOG; and (2) the key determinants of the effectiveness of the intervention to reduce the impact of anxiety and stress on FOG.

Study design:

This study is a randomized controlled trial (RCT). The intervention group will receive the intervention immediately after randomization while a (waitlist) control group receives the same intervention thereafter.

Study population:

Forty people with PD that experience daily FOG (as objectified with the new-freezing of gait questionnaire) will be included, that is related to anxiety (positive answer to the question: Does FOG occur or get worse when you are anxious or stressed?).

Intervention:

The intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient.

Main study parameters/endpoints:

The primary outcome involves the percentage of time frozen during a home-based gait trajectory with self-selected FOG 'hotspots'. Secondary outcomes involve the subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale and the perceived levels of anxiety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Freezing of Gait
• Parkinson Disease

Intervention

Other:
• Psychological intervention
The intervention consists of four sessions of a 'managing the mental state' intervention, of which the first and second session will take place in the home-setting of the patient; the two remaining sessions will take place remotely. The sessions include psychoeducation on what anxiety is and how stress and anxiety can influence FOG, identifying how people are allocating attention and engage in specific thought-processes (e.g. worrisome thoughts) during walking, and educating patients about 'managing the mental state' compensation strategies that involve ways to reduce anxiety or stress and will be specifically tailored to the individual patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Montreal Cognitive Assessment	The Montreal cognitive assessment will be measured at baseline to determine cognitive status	Baseline
Other	Unified Parkinson's Disease Rating Scale Part III	Part III of the UPDRS is a physical examination that examines the severity of Parkinson's Disease motor symptoms. The UPDRS will be administered at baseline to measure Parkinson's Disease severity	Baseline
Primary	% time frozen during a personalized gait trajectory	The primary outcome measure involves the percentage of time frozen during a personalized walking trajectory that includes self-selected FOG 'hotspots' in the home setting. This gait trajectory will be exactly the same during the baseline and consecutive measurements, and will be performed at comfortable gait speed. The gait trajectory will be video-taped by the assessor and performed three times during each visit.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale	subjective impact of anxiety and stress on FOG, as measured with a Visual Analogue Scale	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	Heart Rate Variability	Heart rate variability (HRV) will be measured to determine whether the gait measures induce physiological stress and to examine if the intervention leads to a reduction in physiological stress. For this purpose, we will collect 3-lead electrocardiogram signals for heart rate monitoring prior to and during the gait measures	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	The Parkinson Anxiety Scale (PAS)	The Parkinson Anxiety Scale (PAS) [9] is a questionnaire that has been specifically developed for measuring anxiety in people with PD.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	Gait-Specific Attention Profile	The Gait-specific attentional profile (G-SAP) provides measurements of multiple psychological factors that influence gait performance. The G-SAP will be administered in order to determine whether psychological factors that are implicated in gait performance (e.g., conscious processing of movement, fall-related ruminations) are changed in response to the intervention	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	he Updated Perceived Control over Falling Scale (UP-COF)	The Updated Perceived Control over Falling Scale (UP-COF) is a 4-item scale that will be administered to assess whether the intervention improves participants' perceived control over the risk of falling.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	New Freezing of Gait Questionnaire	The New-Freezing of Gait Questionnaire (N-FOGQ) assesses the subjective severity of Freezing of Gait.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	The Parkinson's Disease Questionnaire	The Parkinson's Disease Questionnaire (PDQ-39) will be administered to measure quality of life.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	The Rosenberg self-esteem score	The Rosenberg self-esteem score will be administered in order to assess self-esteem.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)
Secondary	Perceived Stress Scale	The Perceived Stress Scale will be administered in order to determine whether the intervention leads to a decrease in perceived levels of stress.	Baseline, week after the intervention has ended (5 weeks from baseline) and 10 week follow-up (15 weeks from baseline)