NCT03416452

Gait Disorders in Parkinson's Disease

Withdrawn EARLY_PHASE1 Last updated 20 November 2018

What this trial tests

EARLY_PHASE1 trial testing vibratory cueing device in Parkinson's Disease. Withdrawn.

Timeline

24 January 2018

Primary endpoint
13 November 2018

13 November 2018

Quick facts

Lead sponsor	National Institute of Neurological Disorders and Stroke (NINDS)
Phase	EARLY_PHASE1
Status	Withdrawn
Study type	INTERVENTIONAL
Design	parallel
Masking	none
Primary purpose	supportive care
Start date	24 January 2018
Primary completion	13 November 2018
Estimated completion	13 November 2018

Drugs / interventions tested

• vibratory cueing device
• Mobile Gait Trainer

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Who can join

18 and older, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Parkinson s disease (PD) is a neurologic disorder that causes slowness, tremor, rigidity, and imbalance. Gait impairment is also common. There are 2 substudies: (1) Physiology of Freezing and Gait; (2) Vibratory Cueing. Healthy participants can join only Substudy 1.

Objective:

To study gait disorders in PD. Also, to test the effect of specific interventions for gait in people with PD.

Eligibility:

People ages 18 and older who:

Have PD with bilateral symptoms but can walk without a cane or walker

Are healthy

Design:

Participants will be screened in Protocols 93-N-0202 and 01-N-0206.

Both substudies include a physical exam and medical history.

Substudy 1:

Participants will have one 6-hour visit. They must wear a tank tops and shorts with tennis shoes during the visit. They will perform gait tasks. Markers placed on the skin will record movements. They will have an EEG: They will wear an electrode cap to record brain waves. They will wear special glasses to record eye movements. Participants with PD will hold their morning dose of PD drugs. They can choose to be admitted to the hospital the previous evening. Otherwise someone else or a taxi must bring them to the visit. They will first perform the study tasks off their drugs. Then they will take their drugs and repeat them.

Substudy 2:

Participants will have one 3-hour visit. A small vibratory device will be attached to their ankle. Reflective markers placed on the skin will record movements while they walk:

Without the device

With the device, but the vibrator off

With the device, with the vibrator on

With a magnet attached to the ankle

Publications & conference data

No peer-reviewed publications indexed yet for this trial.