Evaluation of Muscle Contraction in People With PDNCT05693207
EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
A study testing EMG in people with Evaluation of Muscle Contraction in People With PD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. Read more about this study
- Who is it for?
- Ages 40 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluation of Muscle Contraction in People With PD
- What is being tested?
- EMG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Oct 2021to 23 Dec 2023
- Phase
- Interventional
- 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 40 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 40-89.
- Patients with idiopathic Parkinson's disease according to the diagnosis of a neurologist, who are able to walk with or without a walking aid for at least 5 minutes.
- 21 or above in MoCA test.
- people who gave their written and oral consent to participate in the study.
- Men and women aged 40-89.
- 24 or above in MoCA test.
Show all 10Show fewer
- Without a neurological, cardiovascular or orthopedic disorder, which could affect the normal walking pattern, and all within the researcher's decision.
- Criteria for exclusion from the experiment:
- The patient has serious side effects that are not suitable for continuing in the study.
- The patient does not wish to continue his participation in the study.
Who cannot join
- Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.
- History of head injury - traumatic brain injury or cerebrovascular accident (CVA)
- This study will not include pregnant women and children.
Trial locations and contacts
1 site in 1 country.
David Buzaglo, B.pt contact
Israel1 site, 1 recruiting
- Recruiting
Tel aviv medical center
Tel Aviv
David Buzaglo, B.pt, +972 36947513, davidbuz@tlvmc.gov.il
Marina Brozgol, M.sc, +972 36947513, marinab@tlvmc.gov.il
About this study
The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.
Read the detailed description
The subject will arrive independently at the Tel Aviv Medical Center. After explaining the course of the study and signing a consent form, the subject will be administered the MoCA questionnaire to assess the cognitive state.
During this session, the patient will undergo gait evaluation using motion sensors and an EMG device.
This meeting will last up to an hour, according to the following breakdown:
Explanation of the test (10 min) Preparing the skin (light disinfection with alcohol) for EMG adhesion (10 min.) Performing of the test (20 minutes) Summary and discharge (5 min).
- Being tested
- EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMGDevice
Also called Accelerometers and gyroscopes
wearables EMG
| Study group | Role | What they receive |
|---|---|---|
| People with iPD with freezing of gait | Experimental | Not described Receives: Device: EMG |
| People with iPD without freezing of gait | Other | control group Receives: Device: EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage time of co-contractions
The time of co-contraction during walking will be higher among people with FOG.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start7 Oct 2021
- Primary completion23 May 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Evaluation of Muscle Contraction in People With PDStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nir Giladi, Prof, Principal investigator, Study Principal Investigator Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693207
- Sponsor's protocol ID
- TASMC-21-NG-0515-CTIL
- Status last verified
- Nov 2022
- First submitted
- 27 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.
PubMed 24976103Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.
PubMed 15300651Silva de Lima AL, Evers LJW, Hahn T, Bataille L, Hamilton JL, Little MA, Okuma Y, Bloem BR, Faber MJ. Freezing of gait and fall detection in Parkinson's disease using wearable sensors: a systematic review. J Neurol. 2017 Aug;264(8):1642-1654. doi: 10.1007/s00415-017-8424-0. Epub 2017 Mar 1.
PubMed 28251357Hanein Y, Mirelman A. The Home-Based Sleep Laboratory. J Parkinsons Dis. 2021;11(s1):S71-S76. doi: 10.3233/JPD-202412.
PubMed 33682729Inzelberg L, David-Pur M, Gur E, Hanein Y. Multi-channel electromyography-based mapping of spontaneous smiles. J Neural Eng. 2020 Apr 9;17(2):026025. doi: 10.1088/1741-2552/ab7c18.
PubMed 32271717Mazzetta I, Zampogna A, Suppa A, Gumiero A, Pessione M, Irrera F. Wearable Sensors System for an Improved Analysis of Freezing of Gait in Parkinson's Disease Using Electromyography and Inertial Signals. Sensors (Basel). 2019 Feb 23;19(4):948. doi: 10.3390/s19040948.
PubMed 30813411
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG to Detect and Monitor Freezing of Gait Among People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05693207
- Acronym / sponsor ID
- TASMC-21-NG-0515-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 23 May 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 20 Jan 2023 (actual)
- 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.
The main goal of this study is to evaluate, via EMG (electromyography) system, the muscle activity in the lower limbs, to understand the contribution of the muscle activity to FOG (freezing of gait) in Parkinson's patients. The phenomenon of FOG appears in advanced cases of Parkinson's disease (PD) and can lead to an increased risk of falls. There are several approaches claiming that there is abnormal activity in the calf muscles and the freezing events in Parkinson's patients. In the clinic, monitoring FOG is done subjectively, usually through observations or through questionnaires. As a result, the information about the phenomenon may be biased and insensitive. With an electromyographic monitor (EMG), objective information about the muscular activity during normal walking and during unusual events can be obtained.
Detailed description
The subject will arrive independently at the Tel Aviv Medical Center. After explaining the course of the study and signing a consent form, the subject will be administered the MoCA questionnaire to assess the cognitive state.
During this session, the patient will undergo gait evaluation using motion sensors and an EMG device.
This meeting will last up to an hour, according to the following breakdown:
Explanation of the test (10 min) Preparing the skin (light disinfection with alcohol) for EMG adhesion (10 min.) Performing of the test (20 minutes) Summary and discharge (5 min).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with iPD with freezing of gait | Experimental | Device: EMG |
| People with iPD without freezing of gait | Other | Device: EMGcontrol group |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged 40-89.
- Patients with idiopathic Parkinson's disease according to the diagnosis of a neurologist, who are able to walk with or without a walking aid for at least 5 minutes.
- 21 or above in MoCA test.
- people who gave their written and oral consent to participate in the study.
- Men and women aged 40-89.
Key exclusion criteria (3 listed)
- Neurological or other psychiatric disorder (such as MSA, PSP, after a stroke with neurological signs, dementia diseases, clinical depression) at the researcher's decision.
- History of head injury - traumatic brain injury or cerebrovascular accident (CVA)
- This study will not include pregnant women and children.
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 |
|---|---|---|
| EMGAlso: Accelerometers and gyroscopeswearables EMG | Device | People with iPD with freezing of gait, People with iPD without freezing of gait |
Primary outcome
Percentage time of co-contractions
Time frame: 60 minutes
The time of co-contraction during walking will be higher among people with FOG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 24976103Pringsheim T, Jette N, Frolkis A, Steeves TD. The prevalence of Parkinson's disease: a systematic review and meta-analysis. Mov Disord. 2014 Nov;29(13):1583-90. doi: 10.1002/mds.25945. Epub 2014 Jun 28.
- Background: PubMed 15300651Bloem BR, Hausdorff JM, Visser JE, Giladi N. Falls and freezing of gait in Parkinson's disease: a review of two interconnected, episodic phenomena. Mov Disord. 2004 Aug;19(8):871-84. doi: 10.1002/mds.20115.
- Background: PubMed 28251357Silva de Lima AL, Evers LJW, Hahn T, Bataille L, Hamilton JL, Little MA, Okuma Y, Bloem BR, Faber MJ. Freezing of gait and fall detection in Parkinson's disease using wearable sensors: a systematic review. J Neurol. 2017 Aug;264(8):1642-1654. doi: 10.1007/s00415-017-8424-0. Epub 2017 Mar 1.
- Background: PubMed 33682729Hanein Y, Mirelman A. The Home-Based Sleep Laboratory. J Parkinsons Dis. 2021;11(s1):S71-S76. doi: 10.3233/JPD-202412.
- Background: PubMed 32271717Inzelberg L, David-Pur M, Gur E, Hanein Y. Multi-channel electromyography-based mapping of spontaneous smiles. J Neural Eng. 2020 Apr 9;17(2):026025. doi: 10.1088/1741-2552/ab7c18.
- Background: PubMed 30813411Mazzetta I, Zampogna A, Suppa A, Gumiero A, Pessione M, Irrera F. Wearable Sensors System for an Improved Analysis of Freezing of Gait in Parkinson's Disease Using Electromyography and Inertial Signals. Sensors (Basel). 2019 Feb 23;19(4):948. doi: 10.3390/s19040948.
- Individual participant dataSharing planned: No
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.
David Buzaglo, B.pt contact
Nir Giladi, Prof principal investigator
Study Principal Investigator Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG in people with Evaluation of Muscle Contraction in People With PD, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Hausdorff, Phd (972-3-6974958, jhausdor@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage time of co-contractions (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693207, which also lists 6 linked publications.
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 20 Jan 2023.