Parkinson DiseaseEarly Phase 1NCT00762814
The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
A Early Phase 1 study testing Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit) in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Program in Physical Therapy
St Louis, Missouri, 63108
About this study
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)
- Keywords
- Parkinson disease, Individuals, frequent, freezing, during, gait
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
Measured: Time of study visit
Secondary outcomes (2)
Time to perform a 360 degree turn while standing in place
Measured: Time of study visit
Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject
Measured: Time of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2009
- Study completionJun 2009
Why it stopped: There was no funding for the device to be used in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762814
- Sponsor's protocol ID
- 07-0890
- Status last verified
- May 2018
- First submitted
- 23 Sep 2008
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT00762814
- Acronym / sponsor ID
- 07-0890
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Individuals, frequent, freezing, during, gait
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was no funding for the device to be used in the study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson subjects with freezing | Experimental | Device: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit)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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Parkinson subjects with freezing |
Primary outcome
Timed Up and Go
Time frame: Time of study visit
2 secondary outcomes
Time to perform a 360 degree turn while standing in place
Time frame: Time of study visit
Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject
Time frame: Time of study visit
Results and safety
The study was stopped early (reason given: There was no funding for the device to be used in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit) in people with Parkinson Disease, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: There was no funding for the device to be used in the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (time frame: Time of study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.