Freezing of GaitPhase 4NCT06316232
DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
A Phase 4 study testing STIM ON plus and MED ON plus in people with Freezing of Gait and Parkinson Disease, run by IRCCS Istituto delle Scienze Neurologiche di Bologna at 1 site in Italy.
Trial summary
Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Freezing of Gait, Parkinson Disease
- What is being tested?
- STIM ON plus and MED ON plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2023to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)
- History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.
Who cannot join
- inability to walk independently for 10 meters.
- limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects
- previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.
- dementia (MMSE score ≤ 18)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, 40139
Ilaria Cani, 0039 051 4966959, ilaria.cani@studio.unibo.it
Giulia Giannini, 0039 051 4966959, giulia.giannini15@unibo.it
About this study
Official title: Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.
In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.
Read the detailed description
This is a cross-over, blind, randomized study to evaluate the improvement of FoG in a group of PD patients treated with bilateral STN-DBS by increasing the intensity of stimulation (STIM plus) or administering a higher dose of levodopa (MED plus).
Patient will be videorecorded for evaluation of freezing episodes and gait cinematic parameters by means of 3 wearable inertial sensors on the feet and at lumbar level during a standardized walking protocol including: Timed Up and Go, Turn 360°, Gait 18 m and a Complex task in single task and dual task (serial-3 subtractions) conditions. In each condition, Tinetti scale, Trail Making Test, alternate fluency test, Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) and MDS Unified Dyskinesia Rating Scale (UDysRS) will be also perform.
In addition, other demographic and clinical information such as age, sex, MMSE, MoCA, New Freezing of Gait Questionnaire, Falls Efficacy Scale will be collected.
The primary endpoint of this study is to investigate the efficacy of increasing intensity of stimulation (STIM plus) or levodopa (MED plus) on freezing of gait (FOG).
Secondary outcome measures include cinematic gait parameters, global motor outcomes and cognitive functions.
- Conditions
- Freezing of Gait, Parkinson Disease
- Being tested
- STIM ON plus, MED ON plus
- Keywords
- freezing of gait, gait disturbances, parkinson disease
- Medical subject headings
- Parkinson Disease, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIM ON plusDevice
increase of intensity of stimulation of 0.5 mA bilaterally
MED ON plusDrug
administration of a 2x levodopa morning dose
| Study group | Role | What they receive |
|---|---|---|
| STIM ON plus/MED ON plus | Active comparator | Patients were evaluated in two following morning sessions under different treatment conditions:
1. STIM ON plus (intervention 1)
2. MED ON plus (intervention 2) Receives: Device: STIM ON plus; Drug: MED ON plus |
| MED ON plus/STIM ON plus | Active comparator | Patients were evaluated in two following morning sessions under different treatment conditions:
1. MED ON plus (intervention 2)
2. STIM ON plus (intervention 1) Receives: Device: STIM ON plus; Drug: MED ON plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with FOG during protocol
Video-assessed reduction in the total time of FoG during the standardize walking protocol in MED ON plus or STIM ON plus condition compared to baseline.
Measured: immediate post monitoring
Secondary outcomes (5)
Gait performance
Changes in gait parameters measured by a system of 3 wearable inertial sensors, including: gait speed, stride lenght, number of step, cadence, gait variability, left-right asymmetry during MED ON plus or STIM ON plus protocol compared to baseline.
Measured: immediate post monitoring
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Change in items 3.10 and 3.11 MDS UPDRS part III and total score between MED ON plus or STIM ON plus condition and baseline.
Measured: immediate post monitoring
Patient global impression of change (PGI-C)
Change in PGI-C scores on MED ON plus or STIM ON plus condition compared to baseline.
Measured: immediate post monitoring
Trail Making test A and B
Change in Trail Making test A and B scores during MED ON plus or STIM ON plus protocol compared to baseline.
Measured: immediate post monitoring
Phonemic/Semantic alternate Fluency test
Change in during Phonemic/Semantic alternate Fluency test scores between MED ON plus or STIM ON plus condition and baseline.
Measured: immediate post monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Freezing of GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions: 1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally, 2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Istituto delle Scienze Neurologiche di Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza
- Responsible party
- Principal investigator, Ilaria Cani, IRCCS Istituto delle Scienze Neurologiche di Bologna
- Investigators
- Ilaria Cani, Principal investigator, IRCCS Istituto delle Scienze Neurologiche di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316232
- Sponsor's protocol ID
- DBS-FOG 2023
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study
- ClinicalTrials.gov ID
- NCT06316232
- Acronym / sponsor ID
- DBS-FOG 2023
- Conditions
- Freezing of Gait, Parkinson Disease
- Keywords
- freezing of gait, gait disturbances, parkinson disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IRCCS Istituto delle Scienze Neurologiche di BolognaUniversity, hospital or other
- Collaborators
- A.O.U. Città della Salute e della Scienza
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.
In this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.
Detailed description
This is a cross-over, blind, randomized study to evaluate the improvement of FoG in a group of PD patients treated with bilateral STN-DBS by increasing the intensity of stimulation (STIM plus) or administering a higher dose of levodopa (MED plus).
Patient will be videorecorded for evaluation of freezing episodes and gait cinematic parameters by means of 3 wearable inertial sensors on the feet and at lumbar level during a standardized walking protocol including: Timed Up and Go, Turn 360°, Gait 18 m and a Complex task in single task and dual task (serial-3 subtractions) conditions. In each condition, Tinetti scale, Trail Making Test, alternate fluency test, Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) and MDS Unified Dyskinesia Rating Scale (UDysRS) will be also perform.
In addition, other demographic and clinical information such as age, sex, MMSE, MoCA, New Freezing of Gait Questionnaire, Falls Efficacy Scale will be collected.
The primary endpoint of this study is to investigate the efficacy of increasing intensity of stimulation (STIM plus) or levodopa (MED plus) on freezing of gait (FOG).
Secondary outcome measures include cinematic gait parameters, global motor outcomes and cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions: 1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally, 2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation.
| Arm | Type | Receives |
|---|---|---|
| STIM ON plus/MED ON plus | Active comparator | Device: STIM ON plus, Drug: MED ON plusPatients were evaluated in two following morning sessions under different treatment conditions: 1. STIM ON plus (intervention 1) 2. MED ON plus (intervention 2) |
| MED ON plus/STIM ON plus | Active comparator | Device: STIM ON plus, Drug: MED ON plusPatients were evaluated in two following morning sessions under different treatment conditions: 1. MED ON plus (intervention 2) 2. STIM ON plus (intervention 1) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)
- History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.
Key exclusion criteria (4 listed)
- inability to walk independently for 10 meters.
- limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects
- previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.
- dementia (MMSE score ≤ 18)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STIM ON plusincrease of intensity of stimulation of 0.5 mA bilaterally | Device | MED ON plus/STIM ON plus, STIM ON plus/MED ON plus |
| MED ON plusadministration of a 2x levodopa morning dose | Drug | MED ON plus/STIM ON plus, STIM ON plus/MED ON plus |
Primary outcome
Time spent with FOG during protocol
Time frame: immediate post monitoring
Video-assessed reduction in the total time of FoG during the standardize walking protocol in MED ON plus or STIM ON plus condition compared to baseline.
5 secondary outcomes
Gait performance
Time frame: immediate post monitoring
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III
Time frame: immediate post monitoring
Patient global impression of change (PGI-C)
Time frame: immediate post monitoring
Trail Making test A and B
Time frame: immediate post monitoring
Phonemic/Semantic alternate Fluency test
Time frame: immediate post monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Freezing of Gait
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Not yet recruiting
Function-based Accelerated Stimulation Therapy (FAST-therapy) for Freezing of Gait (FOG) After Parkinson's Disease (PD)
Parkinson Disease
Active, not recruitingPhase 2
Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease
Freezing of Gait, Parkinson Disease
RecruitingObservational study
Visuomotor Control in Parkinson Disease
Parkinson Disease
Recruiting
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Parkinson Disease, Gait Disorders, Neurologic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ilaria Cani principal investigator
IRCCS Istituto delle Scienze Neurologiche di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing STIM ON plus and MED ON plus in people with Freezing of Gait and Parkinson Disease, run by IRCCS Istituto delle Scienze Neurologiche di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Cani (0039 051 4966959, ilaria.cani@studio.unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with FOG during protocol (time frame: immediate post monitoring). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.