Transcranial Direct Current Stimulation for Freezing of Gait

Parkinson's Disease Clinical Trial

— TDCS-FOG  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02266004
• Other study ID #: 20140127
• Status: Terminated
• Phase: N/A
• Start date: September 12, 2014
• Est. completion date: June 27, 2018

Study information

• Verified date: June 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 27, 2018
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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:
• locomotor training
An individualized dual-task walking program for approximately 30 minutes.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Walking Speed	walking speed will be measured using sensors during a 90 second walk	baseline, 3 weeks
Secondary	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
Secondary	Change in Stride Length	Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.	baseline, 3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio	Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).	baseline, 3 weeks
Secondary	Change in Backward Digit Span	Digit span is measured by total number of correct digits recited.	baseline, 3 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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