Transcranial Direct Current Stimulation for Freezing of Gait

NCT02266004 | Terminated Results FDA Device

• 1 other identifier: 20140127
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease

Keywords

transcranial direct current stimulation; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in Walking Speed

  walking speed will be measured using sensors during a 90 second walk

  baseline, 3 weeks

Secondary Outcomes (11)

• Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)

  baseline, 3 weeks

• Change in Stride Length

  baseline, 3 weeks

• Change in Postural Sway

  baseline, 3 weeks

• Change in Timed Up-and-Go (TUG) Time

  baseline, 3 weeks

• Change in Motor Threshold

  baseline, 3 weeks

Study Arms (1)

tDCS+ LT

EXPERIMENTAL

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

Device: Transcranial Direct Current Stimulation (tDCS); Other: locomotor training

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.

Also known as: tDCS

tDCS+ LT

locomotor training OTHER

An individualized dual-task walking program for approximately 30 minutes.

tDCS+ LT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Data was not collected on 4 of the outcome measures due to lack of funding which contributed to the difficulty in performing the tests required per protocol.

Results Point of Contact

• Title: Corneliu Luca, MD
• Organization: University of Miami

cluca@med.miami.edu

305-243-6732

Study Officials

• Corneliu Luca, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Neurology

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 16, 2014
• Study Start: September 12, 2014
• Primary Completion: June 27, 2018
• Study Completion: June 27, 2018
• Last Updated: June 30, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)