NCT04171076

Brief Summary

Spinal cord stimulation has been used to treat gait problems in Parkinson's disease, with positive results along some studies. The use of non-invasive stimulation can be an alternative to stimulate the spinal corn.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
5

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 15, 2019

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2019

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

November 10, 2019

Last Update Submit

November 18, 2019

Conditions

Parkinson DiseaseGait, Rigid

Outcome Measures

Primary Outcomes (1)

  • Freezing of gait score

    The primary outcome is the freezing of gait score. 12-item scale, each item scores 3 points at maximum; the score ranges from 0-36; higher scores mean higher severity

    One week

Secondary Outcomes (4)

  • Gait speed

    baseline, 1 week, 4 week

  • Freezing of gait questionnaire

    baseline, 1 week, 4 week

  • Safety of the intervention - urinary incontinence

    1 week, 4 week

  • Safety of the intervention - lower limb strength.

    1 week, 4 week

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention: non-invasive spinal cord stimulation

Procedure: Transcutaneous spinal cord stimulation

Interventions

Transcutaneous spinal cord stimulationPROCEDURE

Theta burst stimulation at thoracic level (T5) over 2 minutes

Intervention

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Detailsaged 18 years or higher
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of advanced idiopathic Parkinson's disease
  • significant freezing of gait despite optimized treatment with medications and rehabilitation program

You may not qualify if:

  • psychiatric symptoms
  • dementia
  • cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Pilot study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 10, 2019

First Posted

November 20, 2019

Study Start

October 15, 2019

Primary Completion

November 15, 2019

Study Completion

November 30, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Locations

BR(1)