ParkinsonNCT02896816
EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
A study testing Surface EMG, MRI and PET Scan and Surface EMG in people with Parkinson, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
Study Purpose: Parkinson's disease leads to severally impaired motor control. The purpose of this study is to better understand and analyze the characteristics of arm muscle activity while doing some reaching tasks and of leg muscles while walking. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson
- What is being tested?
- Surface EMG, MRI and PET Scan and Surface EMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 25 May 2021
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female, age 18-80
- Motor symptoms only on one side of the body
- No use of dopaminergic replacement therapy or other medication related to PD
- Male and female, age 18-80
- Age and gender-matched to PD patients
- No use of dopaminergic replacement therapy or other medication related to PD
Who cannot join
- Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
- Subjects who are unable to perform arm reaching movements
- Self-report of any condition that could affect walking
- No fractures or skin lesions in the upper or lower limbs
- Infectious diseases requiring contact precautions
- Subjects with contraindications to MRI cannot participate (i.e., implanted metal including pacemakers, cerebral spinal fluid shunts, aneurysm clips, artificial heart valves, ear implants or metal/foreign objects in the eyes and those with a history of claustrophobia)
Show all 19Show fewer
- Pregnancy: If the possibility of pregnancy of a female participant cannot be excluded by: 1) surgical history (e.g., tubal ligation or hysterectomy) or 2) post menopausal status with a minimum of 1 year without menses, then a pregnancy test by stat serum testing must be performed on site the morning of any PET visit and the negative result is required prior to the administration or any radiopharmaceutical
- Substance abuse within the past 2 years as it may alter neurotransmitter function
- Active hematological, renal, pulmonary, endocrine or hepatic disorders
- Evidence of cortical infarcts or strategically placed lacunar infarct (e.g. dorsal medial nucleus of thalamus)
- Active cancer, metabolic encephalopathy, infection
- Active cardiovascular disease, stroke, congestive heart failure
- Diagnosis of MCI or dementia
- Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
- Subjects who are unable to perform arm reaching movements
- Self-report of any condition that could affect walking
- No fractures or skin lesions in the upper or lower limbs
- Infectious diseases requiring contact precautions
- Diagnosis of MCI or dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Study Purpose:
Parkinson's disease leads to severally impaired motor control. The purpose of this study is to better understand and analyze the characteristics of arm muscle activity while doing some reaching tasks and of leg muscles while walking. This will allow the investigators to improve understanding of the mechanisms underlying the motor impairments in Parkinson's disease.
Read the detailed description
More details:
A total of 20 participants with Parkinson's disease and 20 age- and gender-matched healthy controls will be included in this study. The participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists. The study will take place at the Motion Analysis Laboratory of Spaulding Rehabilitation Hospital in Charlestown, Massachusetts. It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function.
- Conditions
- Parkinson
- Being tested
- Surface EMG, MRI and PET Scan, Surface EMG
- Keywords
- Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface EMG, MRI and PET ScanOther
It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function.
Surface EMGOther
It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's subjects | Experimental | The participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists.
Surface EMG, MRI and PET scan will be performed at baseline. Receives: Other: Surface EMG, MRI and PET Scan |
| Control subjects | Active comparator | Participants not affected by neurological disorders. Surface EMG will be performed at baseline. Receives: Other: Surface EMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface electromyography recording
Surface EMG upper and lower extremities
Measured: Baseline
Secondary outcomes (4)
Structural MRI
T1 and T2 structural MRI will be performed.
Measured: Baseline
Functional MRI
Resting state and task functional MRI will be performed to obtain BOLD signals.
Measured: Baseline
Diffusion weighted imaging
Diffusion weighted imaging will be performed to obtain connectivity measures.
Measured: Baseline
Altropane PET scan
Altropane PET scan will be performed to assess dopamine transport
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startAug 2016
- Primary completion25 May 2021
- Study completion25 May 2021
Why it stopped: No more funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896816
- Sponsor's protocol ID
- 2015-P-002526
- Status last verified
- Sep 2021
- First submitted
- 29 Jun 2016
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMG Modules as a Novel Biomarker of Basal Ganglia Plasticity in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02896816
- Acronym / sponsor ID
- 2015-P-002526
- Conditions
- Parkinson
- Keywords
- Parkinson's
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No more funding
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Aug 2016 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 12 Sep 2016 (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.
Study Purpose:
Parkinson's disease leads to severally impaired motor control. The purpose of this study is to better understand and analyze the characteristics of arm muscle activity while doing some reaching tasks and of leg muscles while walking. This will allow the investigators to improve understanding of the mechanisms underlying the motor impairments in Parkinson's disease.
Detailed description
More details:
A total of 20 participants with Parkinson's disease and 20 age- and gender-matched healthy controls will be included in this study. The participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists. The study will take place at the Motion Analysis Laboratory of Spaulding Rehabilitation Hospital in Charlestown, Massachusetts. It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's subjects | Experimental | Other: Surface EMG, MRI and PET ScanThe participants with Parkinson's disease should have symptoms only on one side of the body, and they should not be taking any dopamine replacement medication such as levodopa or dopamine agonists. Surface EMG, MRI and PET scan will be performed at baseline. |
| Control subjects | Active comparator | Other: Surface EMGParticipants not affected by neurological disorders. Surface EMG will be performed at baseline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female, age 18-80
- Motor symptoms only on one side of the body
- No use of dopaminergic replacement therapy or other medication related to PD
- Male and female, age 18-80
- Age and gender-matched to PD patients
Key exclusion criteria (19 listed)
- Cognitive impairments that may interfere with understanding instructions as needed during the performance of the study (MMSE<23)
- Subjects who are unable to perform arm reaching movements
- Self-report of any condition that could affect walking
- No fractures or skin lesions in the upper or lower limbs
- Infectious diseases requiring contact precautions
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 |
|---|---|---|
| Surface EMG, MRI and PET ScanIt will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function. | Other | Parkinson's subjects |
| Surface EMGIt will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. | Other | Control subjects |
Primary outcome
Surface electromyography recording
Time frame: Baseline
Surface EMG upper and lower extremities
4 secondary outcomes
Structural MRI
Time frame: Baseline
Functional MRI
Time frame: Baseline
Diffusion weighted imaging
Time frame: Baseline
Altropane PET scan
Time frame: Baseline
Results and safety
The study was stopped early (reason given: No more funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface EMG, MRI and PET Scan and Surface EMG in people with Parkinson, run by Spaulding Rehabilitation Hospital 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 6 inclusion and 19 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 4 Oct 2021. 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.
Are results available for this study?
The study was stopped early (reason given: No more funding). 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?
Surface electromyography recording (time frame: Baseline). 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 4 Oct 2021.