Parkinson DiseaseSCP-FOGNCT05415774
Combined Deep Brain Stimulation in Parkinson's Disease
A study testing 1 : S-C1-C2, 2 : S-C2-C1 and 3 : C1 - S - C2 in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 1 : S-C1-C2, 2 : S-C2-C1 and 3 : C1 - S - C2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 stable parkinsonian stimulation parameters and anti-parkinsonian treatments for one month before the inclusion visit;
- Patients with H/Y stage ≤ 3 in the Med ON/Stim On condition (at 130Hz, S-stimulation);
Who cannot join
- 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 whose antiparkinsonian treatments were modified during the last month before inclusion;
- Patient with H\&Y stage ≥4 in Med On/Stim On (at 130Hz, S-stimulation) ;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease: a Pilot Cross-over Study
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.
Read the detailed description
One of the most challenging and unresolved problems in Parkinson's disease (PD) is the treatment of gait disorders, unresponsive to dopaminergic medication. Additionally, PD patients suffering from severe/unresponsive gait disorders are not considered good candidates for subthalamic nucleus deep brain stimulation (STN-DBS). Currently, there are no specific therapies to treat gait disorders in PD with an insufficient response to dopaminergic treatment. Furthermore, axial symptoms develop during disease progression even in operated patients. Axial symptoms are often one of the main causes of disability. There is evidence suggesting that low-frequency (LF) stimulation of the ventral area of the STN can improve axial symptoms. At the same time, the substantia nigra pars reticulata (SNr) is one of the most important output centers of the basal ganglia and is integrated within the locomotor control systems. Neurons within the SNr may act as high-frequency (HF) pacemakers, disrupting normal behavior downstream in the circuit. HF-STN in combination with LF or HF-SNr stimulation have been shown some beneficial effect on freezing of gait (FoG) among PD patients who had FoG unresponsive to dopaminergic therapy. However, only small pilot trials and case series have been investigated this strategy and evidences are scarce.
The aim of this study is to evaluate the effect of combined (C) stimulation of the STN and SNr on FoG if compared to standard (S) stimulation of the STN at 130 Hz, over one month. Based on previous literature evidence as primary aim the respective effect of two setting of C-stimulation will be separately assessed: a) C1- stimulation, with HF stimulation of the STN and SNr using a 'interleaved pulses' at 125 Hz vs. S- stimulation, over one month; b) C2-stimulation with LF stimulation of the SNr at 60Hz and HF stimulation of the STN vs. S- stimulation, over one month.
Other objectives are to evaluate the:
- Tolerance of combined stimulation (STN + SNr) through the collection of adverse events (AEs)
- Development of psychic events such as the presence of depression or dysphoria
- Effect of C (C1 and C2) -stimulation on walking disorders and other axial symptoms if compared vs. the S-stimulation.
- Effect of C (C1 and C2) -stimulation on PD's motor symptoms and motor complications if compared vs. the S-stimulation.
- Effect of C (C1 and C2) -stimulation on sleep quality if compared vs. the S-stimulation.
Each patient will have the 3 types of stimulation:
- One month of S-stimulation (130hz, STN).
- One month of C1- stimulation;
- One month of C2- stimulation;
Stimulation setting order will be randomly assigned. Minimal dopaminergic treatment adjustment will be allowed to minimize the drop-out rate (± 100 mg of levodopa equivalent daily dose) and registered
- Conditions
- Parkinson Disease
- Being tested
- 1 : S-C1-C2, 2 : S-C2-C1, 3 : C1 - S - C2, 4 : C1 -C2 - S, 5 : C2 - S - C1
- Keywords
- freezing of gait, deep brain stimulation, combined deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
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
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
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
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
| Study group | Role | What they receive |
|---|---|---|
| S Stimulation | Active comparator | Standard STN DBS defined as high frequency at 130Hz stimulation Receives: Device: 1 : S-C1-C2; Device: 2 : S-C2-C1; Device: 3 : C1 - S - C2; Device: 4 : C1 -C2 - S; Device: 5 : C2 - S - C1; Device: 6 : C2 - C1 - S |
| C1 Stimulation | Experimental | Combined high frequency stimulation of the STN and SNr using an interleaved pulses at 125Hz Receives: Device: 1 : S-C1-C2; Device: 2 : S-C2-C1; Device: 3 : C1 - S - C2; Device: 4 : C1 -C2 - S; Device: 5 : C2 - S - C1; Device: 6 : C2 - C1 - S |
| C2 Stimulation | Experimental | Combined low frequency stimulation of the SNr at 60Hz and high frequency stimulation of the STN Receives: Device: 1 : S-C1-C2; Device: 2 : S-C2-C1; Device: 3 : C1 - S - C2; Device: 4 : C1 -C2 - S; Device: 5 : C2 - S - C1; Device: 6 : C2 - C1 - S |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ONE MONTH AFTER INCLUSION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start9 Sep 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margherita FABBRI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415774
- Sponsor's protocol ID
- RC31/21/0609
- Acronym
- SCP-FOG
- Status last verified
- Dec 2023
- First submitted
- 8 Jun 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39957196
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Deep Brain Stimulation of the Substantia Nigra Pars Reticulata and of the Subthalamic Nucleus for Unresponsive Freezing of Gait in Parkinson's Disease: a Pilot Cross-over Study
- ClinicalTrials.gov ID
- NCT05415774
- Acronym / sponsor ID
- SCP-FOG / RC31/21/0609
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait, deep brain stimulation, combined deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 13 Jun 2022 (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.
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.
Detailed description
One of the most challenging and unresolved problems in Parkinson's disease (PD) is the treatment of gait disorders, unresponsive to dopaminergic medication. Additionally, PD patients suffering from severe/unresponsive gait disorders are not considered good candidates for subthalamic nucleus deep brain stimulation (STN-DBS). Currently, there are no specific therapies to treat gait disorders in PD with an insufficient response to dopaminergic treatment. Furthermore, axial symptoms develop during disease progression even in operated patients. Axial symptoms are often one of the main causes of disability. There is evidence suggesting that low-frequency (LF) stimulation of the ventral area of the STN can improve axial symptoms. At the same time, the substantia nigra pars reticulata (SNr) is one of the most important output centers of the basal ganglia and is integrated within the locomotor control systems. Neurons within the SNr may act as high-frequency (HF) pacemakers, disrupting normal behavior downstream in the circuit. HF-STN in combination with LF or HF-SNr stimulation have been shown some beneficial effect on freezing of gait (FoG) among PD patients who had FoG unresponsive to dopaminergic therapy. However, only small pilot trials and case series have been investigated this strategy and evidences are scarce.
The aim of this study is to evaluate the effect of combined (C) stimulation of the STN and SNr on FoG if compared to standard (S) stimulation of the STN at 130 Hz, over one month. Based on previous literature evidence as primary aim the respective effect of two setting of C-stimulation will be separately assessed: a) C1- stimulation, with HF stimulation of the STN and SNr using a 'interleaved pulses' at 125 Hz vs. S- stimulation, over one month; b) C2-stimulation with LF stimulation of the SNr at 60Hz and HF stimulation of the STN vs. S- stimulation, over one month.
Other objectives are to evaluate the:
- Tolerance of combined stimulation (STN + SNr) through the collection of adverse events (AEs)
- Development of psychic events such as the presence of depression or dysphoria
- Effect of C (C1 and C2) -stimulation on walking disorders and other axial symptoms if compared vs. the S-stimulation.
- Effect of C (C1 and C2) -stimulation on PD's motor symptoms and motor complications if compared vs. the S-stimulation.
- Effect of C (C1 and C2) -stimulation on sleep quality if compared vs. the S-stimulation.
Each patient will have the 3 types of stimulation:
- One month of S-stimulation (130hz, STN).
- One month of C1- stimulation;
- One month of C2- stimulation;
Stimulation setting order will be randomly assigned. Minimal dopaminergic treatment adjustment will be allowed to minimize the drop-out rate (± 100 mg of levodopa equivalent daily dose) and registered
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| S Stimulation | Active comparator | Device: 1 : S-C1-C2, Device: 2 : S-C2-C1, Device: 3 : C1 - S - C2, Device: 4 : C1 -C2 - S, Device: 5 : C2 - S - C1, Device: 6 : C2 - C1 - SStandard STN DBS defined as high frequency at 130Hz stimulation |
| C1 Stimulation | Experimental | Device: 1 : S-C1-C2, Device: 2 : S-C2-C1, Device: 3 : C1 - S - C2, Device: 4 : C1 -C2 - S, Device: 5 : C2 - S - C1, Device: 6 : C2 - C1 - SCombined high frequency stimulation of the STN and SNr using an interleaved pulses at 125Hz |
| C2 Stimulation | Experimental | Device: 1 : S-C1-C2, Device: 2 : S-C2-C1, Device: 3 : C1 - S - C2, Device: 4 : C1 -C2 - S, Device: 5 : C2 - S - C1, Device: 6 : C2 - C1 - SCombined low frequency stimulation of the SNr at 60Hz and high frequency stimulation of the STN |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ;
Key exclusion criteria (4 listed)
- 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 whose antiparkinsonian treatments were modified during the last month before inclusion;
- Patient with H\&Y stage ≥4 in Med On/Stim On (at 130Hz, S-stimulation) ;
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 |
|---|---|---|
| 1 : S-C1-C2Deep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
| 2 : S-C2-C1Deep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
| 3 : C1 - S - C2Deep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
| 4 : C1 -C2 - SDeep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
| 5 : C2 - S - C1Deep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
| 6 : C2 - C1 - SDeep 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 | Device | C1 Stimulation, C2 Stimulation, S Stimulation |
Primary outcome
Score change of the " New freezing of gait questionnaire "
Time frame: ONE MONTH AFTER INCLUSION
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 39957196Artusi 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.
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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. This study is not recruiting at the moment.
Margherita FABBRI, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 : S-C1-C2, 2 : S-C2-C1 and 3 : C1 - S - C2 in people with Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
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 8 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: finished, as of the sponsor's last update on 6 May 2026. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score change of the " New freezing of gait questionnaire " (time frame: ONE MONTH AFTER INCLUSION). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05415774, which also lists 1 linked publication.
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 6 May 2026.