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Parkinson DiseaseSCS for FOGNCT03526991

Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.

A study testing Spinal Cord Stimulator (SCS) in people with Parkinson Disease, run by Nora Vanegas at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Spinal Cord Stimulator (SCS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
1 Aug 2021to 28 Feb 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females between older than 18 years of age.
  • Able to provide informed consent
  • Diagnosed with idiopathic PD (meeting at least two of the three United Kingdom (UK) Brain Bank criteria for PD, specifically bradykinesia plus resting tremor or rigidity) whose major complaints is levodopa refractory FOG. Levodopa refractoriness will be defined as lack of subjective improvement on FOG episodes as reported by the patient.
  • Documented dopaminergic response
  • Optimized PD treatment including dopaminergic medications, and/or deep brain stimulation (DBS) therapy
  • Presence of at least two self-reported levodopa refractory episodes of FOG per day, not limited to start hesitation
  • At least one witnessed freezing event during the screening visit in the 'on' medication state (defined as 45 minutes after a regular dose of Levodopa for the subject being studied)

Who cannot join

  • Presence of any co-morbid psychiatric illness(es) that would interfere with the completion of the study or pose risk to the patient, as defined below:
  • Presence of psychosis
  • Depression BDI >14
  • Anxiety BAI >14
  • Presence of an active infection, uncontrolled diabetes mellitus, immunosuppression or other medical contraindications to undergoing SCS implantation
  • Patients who are currently on anticoagulation treatment or unable to hold off the anticoagulants (including Plavix, Aspirin, Warfarin, etc.) 7 days prior to the SCS procedure.
Show all 9Show fewer
  • Moderate Cognitive Impairment defined by a MoCA < 23
  • Diagnosis of failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) or intractable low back pain and leg pain.
  • Women of childbearing potential will be excluded as from participation due to the limited safety data of thoracic SCS on the fetus.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Baylor College of Medicine

    Houston, Texas, 77005

  • Columbia University

    New York, New York, 10032

Other trials in United States

About this study

Parkinson Disease (PD) patients experience a variety of motor issues such as walking difficulties, loss of balance, and freezing while walking, which impacts their quality of life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not always improve FOG. Since many traditional therapies have failed for the treatment of FOG, researchers have proposed the use of newer treatments. Recent research in animal models and clinical human data using SCS has produced promising results, specifically showing improvement in FOG with the use of SCS in patients with PD.

The purpose of this study is to evaluate the effectiveness of spinal cord stimulation (SCS) for the management of freezing of gait (FOG) that does not respond to conventional treatments in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS significantly decreases FOG episodes in patients with PD.

  1. Assess the safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
  2. Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.
Read the detailed description

Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by episodes during which patients cannot generate effective forward stepping movements in the absence of motor deficits.

FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver stress. While most motor features of PD respond robustly to dopaminergic agents and deep brain stimulation (DBS), there are currently no effective treatments for FOG.

Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS) for neuropathic pain, has consistently described a positive effect of SCS on FOG. In addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has encouraged us to assemble a multi-disciplinary team for the systematic investigation of the motor effects of SCS on FOG, locomotion and other parkinsonian features.

The current study integrates minimally invasive SCS and the use of robotic technology to determine objective gait parameters. The investigators propose a pilot study for the implantation of SCS to the spinal cord on PD patients with treatment-refractory FOG, including a longitudinal assessment of motor outcomes. Motors assessments will include: PAMSys and LEGSys to characterize gait, ActivePERS motion sensor to monitor ambulation parameters and overall activity at home, participants will also be given electronic tablets for the ActivePERS to collect real time information about falls.

Being tested
Spinal Cord Stimulator (SCS)
Keywords
Freezing of Gait, Locomotion, Spinal cord 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.

  • Spinal Cord Stimulator (SCS)Device

    Also called Proclaim™ Implantable Pulse Generator with leads

    The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space.

    The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental.

Study groups in NCT03526991
Study groupRoleWhat they receive
Spinal Cord Stimulation (SCS) Tonic stimulationExperimentalTonic stimulation
Receives: Device: Spinal Cord Stimulator (SCS)
Spinal Cord Stimulation (SCS) Burst stimulationExperimentalBurst stimulation.
Receives: Device: Spinal Cord Stimulator (SCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Incidence of Adverse Events as assessed by Adverse Event reporting.

    Measured: 12-months

Secondary outcomes (6)

  1. Change in New Freezing of Gait Questionnaire (NFOG-Q) score

    The New Freezing of Gait Questionnaire (NFOG-Q) is a clinician-administered tool that aims to assess both the clinical aspects of FOG as well as its subsequent impairments on quality of life. The task ratings and scales are calculated into a summed NFOG-Q score. The scale is scored from 0-28. A score of 0 means least severe. A score of 28 means the most severe.

    Measured: Baseline (pre-surgery), and over a 12month follow up period

  2. 10-meter walk

    The 10-meter walk measures gait velocity. The 10-meter walk is measured in the length of time duration taken to complete. A lower duration means a higher gait speed. A high duration means a lower gain speed.

    Measured: Baseline (pre-surgery), and over a 12-month follow up period

  3. Montreal Cognitive Assessment (MoCA),

    This is a test of cognitive function used to screen and track cognitive changes over time. The MoCA is scored between 0 - 30 which 0 meaning there is an abnormal amount of cognitive function and 30 meaning there is a normal amount of cognitive function.

    Measured: Baseline (pre-surgery), and over a 12month follow up period

  4. Change in MDS-UPDRS score

    The Movement Disorder Society (MDS) published a revision of the unified Parkinson's disease rating scale, known as the MDS-UPDRS. The Part III: Motor Examination portion of the scale assesses the motor signs of PD and is completed by the examiner. The measure is scored between 0 - 76 with 0 have the most abnormal motor signs and 76 having normal motor signs.

    Measured: Baseline (pre-surgery), and over a 12month follow up period

  5. Non-Motor Symptoms Scale (NMSS)

    Symptoms assessed over the last month. Each symptom scored with respect to: Severity: 0 = None, 1 = Mild: symptoms present but causes little distress or disturbance to patient; 2 = Moderate: some distress or disturbance to patient; 3 = Severe: major source of distress or disturbance to patient. The measure is scored between 0 - 360, with 0 meaning there are no non-motor symptoms and 360 meaning there are non-motor symptoms.

    Measured: Baseline (pre-surgery), and over a 12month follow up period

  6. Parkinson's Disease Questionnaire (PDQ39)

    The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality of life. The measure is scored between 0 - 100 with 0 meaning no health problems and 100 meaning more health problems.

    Measured: Baseline (pre-surgery), and over a 12month follow up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start1 Aug 2021
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

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
Device feasibility
Allocation
Randomised
Intervention model
Crossover
Model description
A total of 10 patients with a diagnosis of Parkinson's disease and treatment refractory freezing of gait will be recruited in this study.
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03526991
Sponsor's protocol ID
H-49023
Acronym
SCS for FOG
Status last verified
Mar 2026
First submitted
4 May 2018
Last updated
19 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Giladi N, Kao R, Fahn S. Freezing phenomenon in patients with parkinsonian syndromes. Mov Disord. 1997 May;12(3):302-5. doi: 10.1002/mds.870120307.

    PubMed 9159723

  • Schoneburg B, Mancini M, Horak F, Nutt JG. Framework for understanding balance dysfunction in Parkinson's disease. Mov Disord. 2013 Sep 15;28(11):1474-82. doi: 10.1002/mds.25613. Epub 2013 Aug 7.

    PubMed 23925954

  • Giladi N, Kao R, Fahn S. Freezing Phenomenon , the Fifth Cardinal Sign of Parkinsonism Freezing Phenomenon in Patients with Parkinsonian Syndromes. 2016;(January). doi:10.1007/978-1-4615-5337-3.

  • Espay AJ, Fasano A, van Nuenen BF, Payne MM, Snijders AH, Bloem BR. "On" state freezing of gait in Parkinson disease: a paradoxical levodopa-induced complication. Neurology. 2012 Feb 14;78(7):454-7. doi: 10.1212/WNL.0b013e3182477ec0. Epub 2012 Jan 18.

    PubMed 22262741

  • Fasano A, Lozano AM. Deep brain stimulation for movement disorders: 2015 and beyond. Curr Opin Neurol. 2015 Aug;28(4):423-36. doi: 10.1097/WCO.0000000000000226.

    PubMed 26110808

  • Fenelon G, Goujon C, Gurruchaga JM, Cesaro P, Jarraya B, Palfi S, Lefaucheur JP. Spinal cord stimulation for chronic pain improved motor function in a patient with Parkinson's disease. Parkinsonism Relat Disord. 2012 Feb;18(2):213-4. doi: 10.1016/j.parkreldis.2011.07.015. Epub 2011 Aug 23. No abstract available.

    PubMed 21865071

  • Soltani F, Lalkhen A. Improvement of Parkinsonian Symptoms With Spinal Cord Stimulation: Consequence or Coincidence? J Neurol Neurosurg Psychiatry. 2013;84(11):e2.74-e2. doi:10.1136/jnnp-2013-306573.165.

  • Hassan S, Amer S, Alwaki A, Elborno A. A patient with Parkinson's disease benefits from spinal cord stimulation. J Clin Neurosci. 2013 Aug;20(8):1155-6. doi: 10.1016/j.jocn.2012.08.018. Epub 2013 Feb 26.

    PubMed 23453160

  • Pinto de Souza C, Hamani C, Oliveira Souza C, Lopez Contreras WO, Dos Santos Ghilardi MG, Cury RG, Reis Barbosa E, Jacobsen Teixeira M, Talamoni Fonoff E. Spinal cord stimulation improves gait in patients with Parkinson's disease previously treated with deep brain stimulation. Mov Disord. 2017 Feb;32(2):278-282. doi: 10.1002/mds.26850. Epub 2016 Nov 10.

    PubMed 27862267

  • Rohani M, Kalsi-Ryan S, Lozano AM, Fasano A. Spinal cord stimulation in primary progressive freezing of gait. Mov Disord. 2017 Sep;32(9):1336-1337. doi: 10.1002/mds.27103. Epub 2017 Jul 6. No abstract available.

    PubMed 28681922

  • Giladi N, Tal J, Azulay T, Rascol O, Brooks DJ, Melamed E, Oertel W, Poewe WH, Stocchi F, Tolosa E. Validation of the freezing of gait questionnaire in patients with Parkinson's disease. Mov Disord. 2009 Apr 15;24(5):655-61. doi: 10.1002/mds.21745.

    PubMed 19127595

  • de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.

    PubMed 16713924

  • Shulman JM, De Jager PL, Feany MB. Parkinson's disease: genetics and pathogenesis. Annu Rev Pathol. 2011;6:193-222. doi: 10.1146/annurev-pathol-011110-130242.

    PubMed 21034221

  • Turner BM, Forstmann BU, Love BC, Palmeri TJ, Van Maanen L. Approaches to Analysis in Model-based Cognitive Neuroscience. J Math Psychol. 2017 Feb;76(B):65-79. doi: 10.1016/j.jmp.2016.01.001. Epub 2016 Feb 17.

    PubMed 31745373

  • Snijders AH, Takakusaki K, Debu B, Lozano AM, Krishna V, Fasano A, Aziz TZ, Papa SM, Factor SA, Hallett M. Physiology of freezing of gait. Ann Neurol. 2016 Nov;80(5):644-659. doi: 10.1002/ana.24778. Epub 2016 Oct 7.

    PubMed 27649270

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulator (SCS) in people with Parkinson Disease, run by Nora Vanegas at 2 sites in United States.

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 7 inclusion and 9 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 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Safety and Tolerability (time frame: 12-months). 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 NCT03526991, which also lists 42 linked publications.

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 19 Mar 2026.

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