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Transcranial Direct Current Stimulation for Freezing of Gait (TDCS-FOG)

Primary Purpose

Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
locomotor training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring transcranial direct current stimulation, neuromodulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age 18- 80
  2. Parkinson's disease stages 2-3 Hoehn and Yahr.
  3. Presence of Freezing of Gait
  4. Stable medication regimen
  5. Time to complete TUG >12 seconds

Exclusion Criteria:

  1. medical condition that would interfere with walking and training for 30 minutes
  2. unable to perform timed up and go in the off condition
  3. history of seizures
  4. implanted deep brain stimulator, pacemaker or any other electronic device.
  5. dementia
  6. Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS+ LT

Arm Description

Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.

Outcomes

Primary Outcome Measures

Change in Walking Speed
walking speed will be measured using sensors during a 90 second walk

Secondary Outcome Measures

Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
Change in Stride Length
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
Change in Postural Sway
Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
Change in Timed Up-and-Go (TUG) Time
Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
Change in Motor Threshold
Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
Change in Backward Digit Span
Digit span is measured by total number of correct digits recited.
Change in the Trail Making Test Time
Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
Change in the Montreal Cognitive Assessment (MOCA)
The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
Change in the Auditory Consonant Trigrams Test (ACT)
The ACT has a score from 0-60 with higher score indicating better performance.
Change in the Freezing of Gait Questionnaire (FOG-Q)
The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.

Full Information

First Posted
October 7, 2014
Last Updated
June 16, 2020
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02266004
Brief Title
Transcranial Direct Current Stimulation for Freezing of Gait
Acronym
TDCS-FOG
Official Title
Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
difficult to recruit participants
Study Start Date
September 12, 2014 (Actual)
Primary Completion Date
June 27, 2018 (Actual)
Study Completion Date
June 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
transcranial direct current stimulation, neuromodulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS+ LT
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
tDCS
Intervention Description
Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
Intervention Type
Other
Intervention Name(s)
locomotor training
Intervention Description
An individualized dual-task walking program for approximately 30 minutes.
Primary Outcome Measure Information:
Title
Change in Walking Speed
Description
walking speed will be measured using sensors during a 90 second walk
Time Frame
baseline, 3 weeks
Secondary Outcome Measure Information:
Title
Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
Description
UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
Time Frame
baseline, 3 weeks
Title
Change in Stride Length
Description
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
Time Frame
baseline, 3 weeks
Title
Change in Postural Sway
Description
Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
Time Frame
baseline, 3 weeks
Title
Change in Timed Up-and-Go (TUG) Time
Description
Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
Time Frame
baseline, 3 weeks
Title
Change in Motor Threshold
Description
Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.
Time Frame
baseline, 3 weeks
Title
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
Description
Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
Time Frame
baseline, 3 weeks
Title
Change in Backward Digit Span
Description
Digit span is measured by total number of correct digits recited.
Time Frame
baseline, 3 weeks
Title
Change in the Trail Making Test Time
Description
Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
Time Frame
baseline, 3 weeks
Title
Change in the Montreal Cognitive Assessment (MOCA)
Description
The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
Time Frame
baseline, 3 weeks
Title
Change in the Auditory Consonant Trigrams Test (ACT)
Description
The ACT has a score from 0-60 with higher score indicating better performance.
Time Frame
baseline, 3 weeks
Title
Change in the Freezing of Gait Questionnaire (FOG-Q)
Description
The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.
Time Frame
baseline, 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18- 80 Parkinson's disease stages 2-3 Hoehn and Yahr. Presence of Freezing of Gait Stable medication regimen Time to complete TUG >12 seconds Exclusion Criteria: medical condition that would interfere with walking and training for 30 minutes unable to perform timed up and go in the off condition history of seizures implanted deep brain stimulator, pacemaker or any other electronic device. dementia Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corneliu Luca, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcranial Direct Current Stimulation for Freezing of Gait

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