Parkinson's DiseaseEarly Phase 1NCT02012647
Subthalamic Deep Brain Stimulation (DBS) in Parkinson's Disease
A Early Phase 1 study testing Transcranial Magnetic Stimulation (TMS) and Motor Physiology Testing in people with Parkinson's Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to examine the brain changes in people with Parkinson's Disease (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and challenging. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and Motor Physiology Testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2016
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-80 years
- Diagnosis of Parkinson's Disease with bilateral subthalamic nucleus (STN) DBS
Who cannot join
- Cardiac pacemakers
- Need for diathermy
- Repeat MRI scanning
- Anticoagulant therapy
- Previous neuro surgical procedure or ablative therapy
- Frank dementia according to cognitive screening
Show all 9Show fewer
- History of seizures
- Pregnancy
- Presence of a terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Cortical Physiology Following Unilateral and Bilateral Subthalamic Deep Brain Stimulation in Parkinson's Disease
The purpose of this study is to examine the brain changes in people with Parkinson's Disease (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and challenging. Deep brain stimulation is an established surgical treatment that is effective for the treatment of PD, but the details of why it helps are not known. In order to achieve maximum benefits from this treatment, it is important to understand how it changes the brain. Specifically, the investigators will study electrophysiology, which is the study of how the brain conducts electrical messages to the rest of the body. To do this, the investigators will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive procedure. They will also conduct motor physiology experiments of the upper and lower limbs to collect data about skeletal muscle movement. The data from this study will help explain whether the electrical changes in the brain have any relation to the physical benefits patients with Parkinson's Disease sometimes receive from DBS surgery.
Read the detailed description
Screening evaluation: The Investigators will ask questions to see if the participant qualifies to be in the study. The screening visit will occur up to 4 months before the first study visit, and can be scheduled to occur on the same day as the first study visit. This evaluation will include a review of medical history and clinical findings related to Parkinson's Disease (if applicable). There may be a neurological exam (physical exam). Women of child bearing potential will take a urine pregnancy test. If applicable, the medications currently used to treat Parkinson's Disease symptoms will be reviewed and subjects will be asked to discontinue them for some hours on the days of the study visits. The investigators do not expect concerns or unwanted consequences arising either from discontinuing the Parkinson's Disease medications or turning off the DBS stimulator for the duration of time proposed in the study.
Participants will be studied under 4 conditions, over a span of as few as two days to as long as two months. The four Conditions are : 1) The DBS stimulator will be turned OFF for both sides. 2) The DBS stimulator will be turned ON for the right side. 3) The DBS stimulator will be turned ON for the left side. 4) The DBS stimulator will be turned ON for both sides. The order of these conditions will be picked randomly.
Participants will be asked not to take PD medications for approximately 12 hours prior to the scheduled visit time, and until after the physiological testing.
Healthy controls will be studied on only one occasion, as they do not have DBS.
Tests performed for each study condition:
- Parkinson's Participants Only: A neurological examination will be performed by administering several clinical scaled. These clinical scales include the Unified Parkinson's Disease Rating Scale (UPDRS), the self-report Parkinson's Disease Quality of life scale (PDQ-39), MMSE instrument for cognitive (or memory) testing, and Beck Depression Inventory (BDI II) for evaluation of mood and depressive symptoms. The PDQ-39, MMSE, and BDI will each only be administered once and therefore will not be repeated at every study visit.
- The investigators will determine individual motor evoked potential (MEP) thresholds before beginning the study treatment. MEP will be recorded from a muscle located between the right thumb and index finger, and then from the left thumb and index finger. MEP threshold refers to the amount of stimulation to the brain that is required to activate muscle cells enough to appear on an electromyography (EMG), which records electrical potential in muscle through electrodes placed on the skin.
- The investigators will use TMS to test motor cortex functions. For these tests, participants will sit in a chair that looks like the one at the dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp.
- The investigators will collect data about the muscles of both the upper and lower limbs with a wireless EMG procedure. To do this, small wireless sensors will be placed on the skin over both arm and leg muscles. Participants will be asked to sit in a chair and perform movements with the upper and lower limbs while the EMG records measurements about movement activity. This procedure will be conducted separately for the upper and lower limbs.
- Participants who have provided consent will be videotaped during the visits.
- Side effects and adverse events pertaining to this study will be recorded at each visit.
- Conditions
- Parkinson's Disease
- Being tested
- Transcranial Magnetic Stimulation (TMS), Motor Physiology Testing
- Keywords
- parkinson, PD, parkinson disease, parkinson's, parkinson's disease, parkinsons, parkinsons disease, TMS, DBS, transcranial magnetic stimulation, deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Procedure or surgery
Participants sit in a chair that looks like one in a dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of the opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. Results will be compared for participants with and without Parkinson's Disease.
Motor Physiology TestingProcedure or surgery
Participants will be asked to move their upper and lower limbs while seated in a chair. Wireless EMG sensors placed on arm and leg muscles will record measurements during this procedure. Upper and lower limb testing will be performed separately.
| Study group | Role | What they receive |
|---|---|---|
| People with Parkinsons Disease | Active comparator | Participants have been diagnosed with Parkinson's Disease, and as recommended by their physicians, have undergone DBS surgery for both sides of the brain. These participants will undergo TMS and motor physiology testing, and results will be compared to participants without Parkinson's Disease. Receives: Procedure: Transcranial Magnetic Stimulation (TMS); Procedure: Motor Physiology Testing |
| Healthy Controls | Placebo comparator | These participants do not have Parkinson's Disease, nor have they had DBS surgery, and are a healthy controls. These participants will undergo TMS and motor physiology testing, and results will be compared to participants with Parkinson's Disease. Receives: Procedure: Transcranial Magnetic Stimulation (TMS); Procedure: Motor Physiology Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Cortex Excitability
We will measure Motor Cortex Excitability by examining circuitries of inhibition found in the motor cortex which have a reduced function in Parkinson's Disease.
Measured: As few as 1 days and up to 4 months
Secondary outcomes (3)
Relation between Unified Parkinson's Disease Rating Scale outcomes and physiological measures
The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108.
The data collected from the UPDRS will be compared to physiological data collected with EMG during limb movement tasks. These tasks are used to gather data about skeletal muscle movements. The EMG data will be evaluated individually with an EMG paradigm considering velocity of movement and both antagonist and agonist burst patterns.
Measured: As few as 2 days and up to 4 months
Transcallosal Pathway Excitability
The investigators will examine the effects of unilateral and bilateral stimulation on the excitability of transcallosal pathway, using specific parameters of Transcranial Magnetic Stimulation (TMS).
Measured: As few as 2 days and up to 4 months
Physiological Measures
Physiological data will be collected from healthy controls with EMG during limb movement tasks. These tasks are used to gather data about skeletal muscle movements. The EMG data will be evaluated individually with an EMG paradigm considering velocity of movement and both antagonist and agonist burst patterns.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aparna Wagle Shukla, MD, Principal investigator, University of Florida Center for Movement Disorders and Neurorestoration
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012647
- Sponsor's protocol ID
- 21-2013
- Other IDs
- 40115065-2
- Status last verified
- Sep 2020
- First submitted
- 1 Nov 2013
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Cortical Physiology Following Unilateral and Bilateral Subthalamic Deep Brain Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02012647
- Acronym / sponsor ID
- 21-2013
- Conditions
- Parkinson's Disease
- Keywords
- parkinson, PD, parkinson disease, parkinson's, parkinson's disease, parkinsons, parkinsons disease, TMS
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Dec 2013 (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.
The purpose of this study is to examine the brain changes in people with Parkinson's Disease (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and challenging. Deep brain stimulation is an established surgical treatment that is effective for the treatment of PD, but the details of why it helps are not known. In order to achieve maximum benefits from this treatment, it is important to understand how it changes the brain. Specifically, the investigators will study electrophysiology, which is the study of how the brain conducts electrical messages to the rest of the body. To do this, the investigators will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive procedure. They will also conduct motor physiology experiments of the upper and lower limbs to collect data about skeletal muscle movement. The data from this study will help explain whether the electrical changes in the brain have any relation to the physical benefits patients with Parkinson's Disease sometimes receive from DBS surgery.
Detailed description
Screening evaluation: The Investigators will ask questions to see if the participant qualifies to be in the study. The screening visit will occur up to 4 months before the first study visit, and can be scheduled to occur on the same day as the first study visit. This evaluation will include a review of medical history and clinical findings related to Parkinson's Disease (if applicable). There may be a neurological exam (physical exam). Women of child bearing potential will take a urine pregnancy test. If applicable, the medications currently used to treat Parkinson's Disease symptoms will be reviewed and subjects will be asked to discontinue them for some hours on the days of the study visits. The investigators do not expect concerns or unwanted consequences arising either from discontinuing the Parkinson's Disease medications or turning off the DBS stimulator for the duration of time proposed in the study.
Participants will be studied under 4 conditions, over a span of as few as two days to as long as two months. The four Conditions are : 1) The DBS stimulator will be turned OFF for both sides. 2) The DBS stimulator will be turned ON for the right side. 3) The DBS stimulator will be turned ON for the left side. 4) The DBS stimulator will be turned ON for both sides. The order of these conditions will be picked randomly.
Participants will be asked not to take PD medications for approximately 12 hours prior to the scheduled visit time, and until after the physiological testing.
Healthy controls will be studied on only one occasion, as they do not have DBS.
Tests performed for each study condition:
- Parkinson's Participants Only: A neurological examination will be performed by administering several clinical scaled. These clinical scales include the Unified Parkinson's Disease Rating Scale (UPDRS), the self-report Parkinson's Disease Quality of life scale (PDQ-39), MMSE instrument for cognitive (or memory) testing, and Beck Depression Inventory (BDI II) for evaluation of mood and depressive symptoms. The PDQ-39, MMSE, and BDI will each only be administered once and therefore will not be repeated at every study visit.
- The investigators will determine individual motor evoked potential (MEP) thresholds before beginning the study treatment. MEP will be recorded from a muscle located between the right thumb and index finger, and then from the left thumb and index finger. MEP threshold refers to the amount of stimulation to the brain that is required to activate muscle cells enough to appear on an electromyography (EMG), which records electrical potential in muscle through electrodes placed on the skin.
- The investigators will use TMS to test motor cortex functions. For these tests, participants will sit in a chair that looks like the one at the dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp.
- The investigators will collect data about the muscles of both the upper and lower limbs with a wireless EMG procedure. To do this, small wireless sensors will be placed on the skin over both arm and leg muscles. Participants will be asked to sit in a chair and perform movements with the upper and lower limbs while the EMG records measurements about movement activity. This procedure will be conducted separately for the upper and lower limbs.
- Participants who have provided consent will be videotaped during the visits.
- Side effects and adverse events pertaining to this study will be recorded at each visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with Parkinsons Disease | Active comparator | Procedure: Transcranial Magnetic Stimulation (TMS), Procedure: Motor Physiology TestingParticipants have been diagnosed with Parkinson's Disease, and as recommended by their physicians, have undergone DBS surgery for both sides of the brain. These participants will undergo TMS and motor physiology testing, and results will be compared to participants without Parkinson's Disease. |
| Healthy Controls | Placebo comparator | Procedure: Transcranial Magnetic Stimulation (TMS), Procedure: Motor Physiology TestingThese participants do not have Parkinson's Disease, nor have they had DBS surgery, and are a healthy controls. These participants will undergo TMS and motor physiology testing, and results will be compared to participants with Parkinson's Disease. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-80 years
- Diagnosis of Parkinson's Disease with bilateral subthalamic nucleus (STN) DBS
Key exclusion criteria (9 listed)
- Cardiac pacemakers
- Need for diathermy
- Repeat MRI scanning
- Anticoagulant therapy
- Previous neuro surgical procedure or ablative therapy
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)Participants sit in a chair that looks like one in a dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of the opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. Results will be compared for participants with and without Parkinson's Disease. | Procedure or surgery | Healthy Controls, People with Parkinsons Disease |
| Motor Physiology TestingParticipants will be asked to move their upper and lower limbs while seated in a chair. Wireless EMG sensors placed on arm and leg muscles will record measurements during this procedure. Upper and lower limb testing will be performed separately. | Procedure or surgery | Healthy Controls, People with Parkinsons Disease |
Primary outcome
Motor Cortex Excitability
Time frame: As few as 1 days and up to 4 months
We will measure Motor Cortex Excitability by examining circuitries of inhibition found in the motor cortex which have a reduced function in Parkinson's Disease.
3 secondary outcomes
Relation between Unified Parkinson's Disease Rating Scale outcomes and physiological measures
Time frame: As few as 2 days and up to 4 months
Transcallosal Pathway Excitability
Time frame: As few as 2 days and up to 4 months
Physiological Measures
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- UF Center for Movement Disorders \& NeurorestorationLink provided by the sponsor.
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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.
Aparna Wagle Shukla, MD principal investigator
University of Florida Center for Movement Disorders and Neurorestoration
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 Transcranial Magnetic Stimulation (TMS) and Motor Physiology Testing in people with Parkinson's Disease, run by University of Florida 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 9 Sep 2020. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor Cortex Excitability (time frame: As few as 1 days and up to 4 months). 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 9 Sep 2020.