NCT04682678

Brief Summary

Our project is based on the fundamental hypothesis that epidural spinal cord stimulation (SCS) improves Freezing of gait (FOG) in patients with Parkinson's disease. In eight patients implantation of electrodes for SCS at the epidural thoracic level will be performed under general anaesthesia. Evaluation of gait and motor symptoms will be performed with and without stimulation, after a 3-month period for each of the stimulation conditions.This is a pilot, single centre, prospective, randomized, double blinded, cross-over study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2021

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

December 8, 2020

Last Update Submit

October 5, 2023

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

  • frequency and duration of Freezing Of Gait (FOG) episodes, objective

    gait testing

    Month 6

Secondary Outcomes (7)

  • frequency and duration of Freezing Of Gait (FOG) episodes, subjective 1

    Month 12

  • frequency and duration of Freezing Of Gait (FOG) episodes, subjective 2

    Month 12

  • impact of spinal cord stimulation on FOG, long term outcome

    Month 12

  • impact of spinal cord stimulation on quality of life, long term outcome

    Month 12

  • impact of SCS on gait during a dual cognitive-motor task test

    Month 12

  • +2 more secondary outcomes

Study Arms (2)

OFF STIM

SHAM COMPARATOR

without stimulation

Procedure: Implantation of electrodes for Spinal cord stimulation

ON STIM

ACTIVE COMPARATOR

stimulation with the most effective parameters

Procedure: Implantation of electrodes for Spinal cord stimulation

Interventions

Implantation of electrodes for Spinal cord stimulationPROCEDURE

The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.

OFF STIMON STIM

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis of idiopathic PD
  • Aged 50-85 years
  • Having a FOG (score\> 14 at New-FOG-Questionnaire; score\> = 1 at item 2.13 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale) despite the optimization of medical treatment
  • Drug treatment stable for at least 2 months
  • Able to give written consent.

You may not qualify if:

  • Pain syndrome (score\> = 2 at item 1.9 of the MDS-UPDRS II)
  • Psychosis
  • Severe depression
  • Severe cognitive impairment (Mini Mental Score Examination \<19)
  • Patient receiving STN DBS treatment
  • Presence of other neurological or medical pathologies interfering with walking
  • Subject under administrative or judicial supervision
  • Subject who cannot be contacted in an emergency.
  • Person with any administrative or judicial measure of deprivation of rights and liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Elena MORO

    CHUGA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 24, 2020

Study Start

March 10, 2021

Primary Completion

July 11, 2023

Study Completion

July 11, 2023

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)