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

Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease

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).

Study Overview

• Status: Terminated
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation (tDCS); Other: locomotor training

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS+ LT; Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.	Device: Transcranial Direct Current Stimulation (tDCS); Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.; Other Names: tDCS; Other: locomotor training; An individualized dual-task walking program for approximately 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Walking Speed	walking speed will be measured using sensors during a 90 second walk	baseline, 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline, 3 weeks
Change in Stride Length	Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.	baseline, 3 weeks
Change in Postural Sway	Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.	baseline, 3 weeks
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.	baseline, 3 weeks
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.	baseline, 3 weeks
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio	Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).	baseline, 3 weeks
Change in Backward Digit Span	Digit span is measured by total number of correct digits recited.	baseline, 3 weeks
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.	baseline, 3 weeks
Change in the Montreal Cognitive Assessment (MOCA)	The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.	baseline, 3 weeks
Change in the Auditory Consonant Trigrams Test (ACT)	The ACT has a score from 0-60 with higher score indicating better performance.	baseline, 3 weeks
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.	baseline, 3 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Corneliu Luca, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2014
• Primary Completion (Actual): June 27, 2018
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; neuromodulation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 20140127

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.: No