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

The Washington University

Status and phase: Terminated; Early Phase 1

Conditions: Parkinson Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00762814

07-0890

Details and patient eligibility

About

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.

Full description

We will use a device (TENS unit) that provides electrical stimulation to a nerve in the lower legs. Electrodes will be placed on the skin of your lower legs and a box that delivers electrical current will cause a tingling feeling in the legs. Subjects will be asked to perform three gait tasks with the device on and off to compare the effects of the sensory cue on the speed/time to complete gait tasks and the frequency and duration of any freezing events. This use of the device (TENS unit) is investigational. While it has been approved by the Food and Drug Administration for the treatment of pain, it has not been approved for the treatment of freezing. Because the TENS unit can provide a sensory cue, it may help to prevent or reduce freezing. If it is found that this cue works, it could lead to new treatments for the treatment of freezing.

Enrollment: 4 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Parkinson subjects with freezing

Experimental group

Description:

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.

Treatment:

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