Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease

May 8, 2023 updated by: University of Sao Paulo General Hospital

Effects of Spinal Cord Stimulation on Gait in Patients With Parkinson´s Disease; a Randomized, Crossover, Double Blinded, Placebo-Controlled Study

Spinal cord stimulation (SCS) for Parkinson´s disease (PD) has been studied for a decade but consensus on efficacy is still lacking, with the previous stimulation standard paresthesia inducing threshold hampering adequate subject blinding. Considering that tonic stimulation for pain has been shown to be efficacious for most patients on subthreshold stimulation parameters we hypothesize a similar result with it´s use on PD. The investigators aim to:

  1. Produce stronger evidence on SCS efficacy for PD in regards to gait, motor scores and quality of life measures by incorporating subthreshold in a randomized cross over placebo-controlled study with a large sample.
  2. Identify predictors of good response to SCS therapy by performing trans spinal magnetic stimulation (TSMS) before SCS implant and correlating the response to SCS to that of the noninvasive TSMS.
  3. Better provide biomarkers of SCS therapy through functional magnetic resonance imaging and electroencephalographic mapping.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Gait impairment in Parkinson´s Disease (PD) is often refractory to standard medication therapy and functional surgery options currently explored resulting in grave loss of independence and quality of life. Spinal cord stimulation (SCS) has been explored for its role in PD after enthusiastic animal studies and despite mixed initial results is currently a very promising candidate for ameliorating hard to treat gait and balance disorders.

Consensus on tonic SCS efficacy is hampered mostly due to small samples and lack of randomized controlled trials so far, and the impossibility of subject blinding due to standard stimulation settings using currents over the paresthesia inducing threshold. Some small studies already attempted subthreshold blinding and all resulted in non significant results, however with no important difference when switching to suprathreshold settings, thus raising the possibility of non responder subjects or inefficient therapy and calling for additional exploration. The investigators aim to explore the feasibility of a placebo controlled trial using subthreshold stimulation with a larger sample and produce stronger evidence on SCS efficacy for PD.

Additionally, the possibility of non responder subjects will be explored by correlating the degree of response to SCS to patient demographic characteristics including age, PD severity and cognition, gait characteristics and the degree of response to trans spinal magnetic stimulation (TSMS), a non invasive magnetic stimulation of upper thoracic spinal region, aiming to identify prognostic factors for the therapy.

Finally, functional magnetic resonance imaging and electroencephalographic mapping will be performed in order to identify biomarkers of SCS therapy.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403000
        • Hospital Das Clinicas Da Faculdade De Medicina Da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed Parkinson´s Disease with Hoehn Yahr scale between 2,5 and 4,0
  • Main complaint of balance or freezing of gait
  • Score of 2 or more on subitem 3.11 of the MDS UPDRS scale concerning Freezing of Gait severity.
  • Capable of informed consent

Exclusion Criteria:

  • Frequent lower limb, lower back or hip pain scoring 3 or more on visual analog scale
  • Uncontrolled or serious comorbidities such as uncontrolled diabetes mellitus, renal disease, anticoagulation, immunosuppression or other medical conditions that present a contraindication for SCS surgery
  • Psychosis, uncontrolled depression (BDI >14) or anxiety disorder (BAI >14)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active stimulation
During active stimulation phase, patients will receive through the spinal cord stimulator active tonic stimulation with amplitude set to 90% of paresthesia inducing threshold, therefore allowing blinding. Patients will be evaluated after a two week wash out period with no stimulation and after two weeks of continuous active stimulation.
Device: Active spinal cord stimulation
Spinal cord stimulation is acomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During active stimulation amplitude will be set to 90% paresthesia inducing threshold.
Sham Comparator: Sham stimulation
During sham stimulation phase, patients will receive through the spinal cord stimulator a zero amplitude stimulation, therefore having no electrical current passing through epidural leads but with the program status still displayed as "on" if checked with patient's personal controller. Patients will be evaluated after a two week wash out period with no stimulation and after two weeks of continuous sham stimulation.
Device: Sham spinal cord stimulation
Spinal cord stimulation is acomplished with surgically implanted epidural leads at Th3 - Th4 levels and a pulse generator implanted in subcutaneous fat. During sham stimulation amplitude will be set to zero.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Timed Up and Go - Test 3 Meters (TUG-Test 3M)
Time Frame: 6 months
Comparison of the change in Timed Up and Go test times between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Part II and III
Time Frame: 6 months
Comparison of change in Unified Parkinson's Disease Rating Scale score part II and III between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting. MDS-PDRS part II is scored from 0 to 52 with higher scores associated with worse motor related daily activities performance. MDS-UPDRS part III is scored from 0 to 132 with higher scores associated with worse motor performance in parkinson related tests.
6 months
Parkinson's Disease Questionnaire (PDQ39)
Time Frame: 6 months
Comparison of change in Parkinson's Disease Questionnaire 39 (PDQ-39) between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting. PDQ39 is score from 0 to 100%, higher values are associated with worse quality of life.
6 months
New Freezing of Gait Questionnaire (NFOG-Q)
Time Frame: 6 months
Comparison of change in New Freezing of Gait Questionnaire (NFOG-Q) score between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting. NFOG-Q is scored from 0 to 28, higher values are associated with more freezing of gait.
6 months
2 minute walk test
Time Frame: 6 months
Comparison of change in gait speed change in 2 minute walk test between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting. Lower values correlate with better gait speed and mobility.
6 months
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: 6 months
Comparison of change in Mini Balance Evaluation Systems Test (Mini-BESTest) test scores between ON-stimulation and baseline and sham-stimulation and baseline in double blinded setting. Minimum value 0 and maximum value 108. Higher value is associated with better balance.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Anticipated)

December 30, 2023

Study Completion (Anticipated)

November 30, 2025

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (Actual)

December 8, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCSPDgait

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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