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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00762814
• Other study ID #: 07-0890
• Status: Terminated
• Phase: Early Phase 1
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
United States	Washington University Program in Physical Therapy	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go		Time of study visit
Secondary	Time to perform a 360 degree turn while standing in place		Time of study visit
Secondary	Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject		Time of study visit