NCT05415774

Brief Summary

The study is a pilot study on Parkinson's disease patients to evaluate Combined deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus for unresponsive freezing of gait.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

May 6, 2026

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

June 8, 2022

Last Update Submit

April 29, 2026

Conditions

Parkinson Disease

Keywords

freezing of gaitdeep brain stimulationcombined deep brain stimulation

Outcome Measures

Primary Outcomes (1)

  • Score change of the " New freezing of gait questionnaire "

    the score change of the means of the New freezing of gait questionnaire at the end of each combined C1 and C2 stimulation, compared to S stimulation at one month of each period. The NFOG-Q is a clinician rated instrument used to evaluate FOG severity in patients with PD, unrelated to falls. Item responses use a 5-point scale ranging from 0 (absence of symptom) to 4 (severe). Total score ranges from 0 to 28; higher scores correspond to more severe FOG. Answers are based on experience over the past week or overall FOG during an entire day.

    ONE MONTH AFTER INCLUSION

Study Arms (3)

S Stimulation

ACTIVE COMPARATOR

Standard STN DBS defined as high frequency at 130Hz stimulation

Device: 1 : S-C1-C2Device: 2 : S-C2-C1Device: 3 : C1 - S - C2Device: 4 : C1 -C2 - SDevice: 5 : C2 - S - C1Device: 6 : C2 - C1 - S

C1 Stimulation

EXPERIMENTAL

Combined high frequency stimulation of the STN and SNr using an interleaved pulses at 125Hz

Device: 1 : S-C1-C2Device: 2 : S-C2-C1Device: 3 : C1 - S - C2Device: 4 : C1 -C2 - SDevice: 5 : C2 - S - C1Device: 6 : C2 - C1 - S

C2 Stimulation

EXPERIMENTAL

Combined low frequency stimulation of the SNr at 60Hz and high frequency stimulation of the STN

Device: 1 : S-C1-C2Device: 2 : S-C2-C1Device: 3 : C1 - S - C2Device: 4 : C1 -C2 - SDevice: 5 : C2 - S - C1Device: 6 : C2 - C1 - S

Interventions

1 : S-C1-C2DEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation
2 : S-C2-C1DEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation
3 : C1 - S - C2DEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation
4 : C1 -C2 - SDEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation
5 : C2 - S - C1DEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation
6 : C2 - C1 - SDEVICE

Deep brain stimulation of the substantia nigra pars reticulata and of the subthalamic nucleus according to the order of randomisation (see intervention name) : * Standard stimulation * 125Hz at both STN and SNr for C1, * 125Hz for STN and 60 for SNr for C2

C1 StimulationC2 StimulationS Stimulation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic PD defined as by the MDS Criteria ;
  • Patients submitted to STN-DBS, for at least 6 months;
  • Patients with STN-DBS at 130Hz;
  • Patients with a troublesome FoG according to the "NFOG-Q", Part II Item II ≥ 2 or Part III Item 7 ≥ 2;
  • Mini Mental State (MMS) ≥ 25 ;
  • Ventral contact of electrodes implanted in the SNr (according to analysis of activated tissue volume models (VTA));
  • Patients with H/Y stage ≤ 3 in the Med ON/Stim On condition (at 130Hz, S-stimulation);

You may not qualify if:

  • Patient with atypical Parkinsonian syndrome;
  • Patient with severe FoG before DBS, i.e. MDS-UPDRS item 2.13 in Med ON ≥2 or MDS-UPDRS item 3.11 ≥2 in Med On;
  • Patient with H\&Y stage ≥4 in Med On/Stim On (at 130Hz, S-stimulation) ;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

  • Artusi CA, Ledda C, Gallo S, Rinaldi D, Campisi C, Rousseau V, Thalamas C, Barbosa R, Ory-Magne F, Brefel-Courbon C, Rascol O, de Barros A, Harroch E, Zibetti M, Rizzone MG, Romagnolo A, Imbalzano G, Lopiano L, Houeto JL, Fabbri M. Subthalamic and nigral stimulation for freezing of gait in Parkinson's disease: Randomized pilot trial. J Parkinsons Dis. 2024 Nov;14(8):1602-1613. doi: 10.1177/1877718X241292315. Epub 2025 Jan 17.

    PMID: 39957196RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Margherita FABBRI, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Single center, randomized, three one-month periods, six sequences, cross-over, double blind, study to evaluate the effect of 2 innovative settings of DBS combining the stimulation of STN and SNr, vs. a standard (S) stimulation, on FoG, in PD patients with DBS with severe FoG. the sequence of different stimulation parameters will be randomized and not the treatment Each patient receives the three treatments (S, C1 and C2)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2022

First Posted

June 13, 2022

Study Start

September 9, 2022

Primary Completion

May 10, 2023

Study Completion

May 10, 2023

Last Updated

May 6, 2026

Record last verified: 2023-12

Locations

FR(1)