Transcranial Direct Current Stimulation for Freezing of Gait

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Device: Transcranial Direct Current Stimulation (tDCS); Other: locomotor training

• Registration Number: NCT02266004
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-12
• Study First Submitted: 2014-10-07
• Study First Submitted QC: 2014-10-10
• Study First Posted: 2014-10-16
• Primary Completion: 2018-06-27
• Study Completion: 2018-06-27
• Results First Submitted: 2020-05-28
• Results First Submitted QC: 2020-05-28
• Status Verified: 2020-06
• Results First Posted: 2020-06-16
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tDCS+ LT	locomotor training	Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.
tDCS+ LT	Transcranial Direct Current Stimulation (tDCS)	Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Change in Walking Speed	baseline, 3 weeks	walking speed will be measured using sensors during a 90 second walk

Secondary Outcome Measures

Name	Time	Method
Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)	baseline, 3 weeks	UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
Change in Postural Sway	baseline, 3 weeks	Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio	baseline, 3 weeks	Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
Change in the Trail Making Test Time	baseline, 3 weeks	Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
Change in Backward Digit Span	baseline, 3 weeks	Digit span is measured by total number of correct digits recited.
Change in Stride Length	baseline, 3 weeks	Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
Change in the Montreal Cognitive Assessment (MOCA)	baseline, 3 weeks	The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
Change in the Freezing of Gait Questionnaire (FOG-Q)	baseline, 3 weeks	The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.
Change in Timed Up-and-Go (TUG) Time	baseline, 3 weeks	Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
Change in Motor Threshold	baseline, 3 weeks	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 the Auditory Consonant Trigrams Test (ACT)	baseline, 3 weeks	The ACT has a score from 0-60 with higher score indicating better performance.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States