The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease

NCT00762814 | Terminated Early Phase 1 DMC

• 1 other identifier: 07-0890
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Some individuals with Parkinson disease experience "freezing" during walking which results in their inability to move their feet. They often have difficulty starting to move once they have stopped. Freezing often results in loss of balance and falling. Oral medications for Parkinson disease aren't as effective in treating freezing as it is in reducing other symptoms. Another treatment for freezing is instruction in walking using visual targets or auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some individuals, but the effects do not last. Other types of cues have not been studied. We want to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on the effects of freezing.

Conditions

Parkinson Disease

Keywords

Parkinson disease; Individuals; frequent; freezing; during; gait

Outcome Measures

Primary Outcomes (1)

• Timed Up and Go

  Time of study visit

Secondary Outcomes (2)

• Time to perform a 360 degree turn while standing in place

  Time of study visit

• Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject

  Time of study visit

Study Arms (1)

Parkinson subjects with freezing

EXPERIMENTAL

Each subject will have been diagnosed with Parkinson disease and will serve as his/her own control. Inclusion criteria: history of consistent freezing with ambulation in a straight line and/or when turning, normal central and peripheral neurological function, at least grade 4 strength and normal joint ranges of motion in both legs, normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa, each must have had clear benefit from levodopa for at least some of his/her PD symptoms, and all subjects with PD must be able to walk independently for 10 feet. Exclusion criteria include: serious medical problem that would impair the ability to undergo testing, use of neuroleptic or other dopamine-blocking drug, use of drugs that might affect balance, history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease, or participants who are unable to provide informed consent.

Device: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)

Interventions

Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit) DEVICE

Eligible subjects will be perform walking tests involving the use of the TENS device (Select Unit by Empi) on the lower leg bilaterally during gait: uncued (wearing the unit but, but with the device turned off) or with a tactile cue (wearing the device with it turned on until a tactile stimulus is felt). The TENS unit is a battery-operated, single-channel electrical stimulator worn around the proximal calf that can used to provide a constant tactile stimulus. All subjects will undergo a single visit in which the two walking conditions are tested. During these visits, the patient will perform the same gait assessments measured with the device turned off as well as turned on. Testing the two conditions on the same day/time will provide the investigators with a consistent comparison of the two tested conditions, as mobility and function in patients with PD can vary significantly within and between days.

Parkinson subjects with freezing

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PD diagnostic criteria include those used for clinically defined "definite PD", as previously outlined22 based upon established criteria.22, 23
• history of consistent freezing with ambulation in a straight line and/or when turning.
• normal central and peripheral neurological function
• at least grade 4 strength and normal joint ranges of motion in both legs
• normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa.
• Each must have had clear benefit from levodopa for at least some of his/her PD symptoms
• All subjects with PD must be able to walk independently for 10 feet.

You may not qualify if:

• serious medical problem that would impair the ability to undergo testing.
• use of neuroleptic or other dopamine-blocking drug
• use of drugs that might affect balance
• history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
• participants who are unable to provide informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University Program in Physical Therapy

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)