Recruiting · registry status

Studying medicines and brain stimulation for feet that feel stuck

Researchers investigate levodopa and deep brain stimulation for freezing of gait, when people with Parkinson’s briefly struggle to take the next step.

Testing a treatment or activity · Study reference: NCT06316232

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date): 2023-10-10
Main measurements finished (planned): 2026-12-31
Study finished (planned): 2026-12-31

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No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded

2026-10-11 — recruiting

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Papers connected to this study

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Who can join?

Ages 18 years to 80 years · Does not accept healthy volunteers

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Sex eligibility reported by registry: all

Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Full study name & original research details

Official study title

Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study

Short title used by the registry

DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease

Original description

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.

Further description from the registry

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 reported: Freezing of Gait; Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

ClinicalTrials.gov · NCT06316232 ↗ — RECRUITING; checked 2026-10-13
ClinicalTrials.gov · NCT06316232 ↗ — Recruiting; WHO ICTRP processed 2024-03-25; checked 2026-10-13

Study type: Interventional
Interventions: STIM ON plus; MED ON plus
Phases: PHASE4
Sponsor: IRCCS Istituto delle Scienze Neurologiche di Bologna
Start date reported by registry: 2023-10-10 (actual)

Registry updated: 2024-03-18 · Status last verified by the registry submitter: 2024-03

Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Ilaria Cani · 0039 051 4966959 · ilaria.cani@studio.unibo.it

Giulia Giannini · 0039 051 4966959 · giulia.giannini15@unibo.it

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

Recruiting

Ilaria Cani · 0039 051 4966959 · ilaria.cani@studio.unibo.it

Giulia Giannini · 0039 051 4966959 · giulia.giannini15@unibo.it

Giovanna Calandra Buonaura, MD, PhD

Ilaria Cani, MD

Carlo Alberto Artusi, MD, PhD

Giulia Giannini, MD, PhD

Facility not reported

Italy

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.