Parkinson's DiseaseNCT01581580
Deep Brain Stimulation Surgery for Movement Disorders
A study testing Deep Brain Stimulation in people with Parkinson's Disease and Essential Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson's Disease, Essential Tremor, Dystonia
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2011to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for entry into the study, candidates must meet all the following criteria:
- Be 18 years of age or older.
- Able to provide informed consent.
- Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:
- idiopathic PD not adequately controlled with medication or
- primary dystonia that is medically refractory, or
- ET that is not adequately controlled by medications or constitutes a significant functional disability.
Who cannot join
- Candidates will be excluded if they:
- Are unable or unwilling to give informed consent to the research procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Background:
- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.
Read more
Objectives:
- To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.
- To obtain information on brain and nerve cell function during DBS surgery.
Eligibility:
- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.
Design:
- Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.
- During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.
- After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.
- Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.
Read the detailed description
Objective:
The objective of this protocol is to collect prospective physiology data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson's disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery.
Study Population:
Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study.
Study Design:
The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment.
Outcome Measures:
The primary goal of this protocol is to characterize motor and cognitive function in people receiving standard of care DBS surgery for movement disorders. Secondary measures include 1) radiographic correlation of DBS electrode position and clinical changes; and 2) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Being tested
- Medtronic Activa Tremor Control System, Deep Brain Stimulation
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Neurophysiology, Movement Disorder, Dystonia, Parkinson Disease, Essential Tremor
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Activa Tremor Control SystemDevice
Medtronic DBS Therapy delivers electrical stimulation to an area in the brain to help treat Parkinson's Disease, dystonia, and essential tremor.
Deep Brain StimulationProcedure or surgery
standard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Other | patients with Parkinson's Disease, dysonia, and essential tremor Receives: Device: Medtronic Activa Tremor Control System; Procedure: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiology and efficacy of DBS surgery for movement disorders
change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study start17 Aug 2011
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Kareem A Zaghloul, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01581580
- Sponsor's protocol ID
- 110211
- Other IDs
- 11-N-0211
- Status last verified
- 2 Jun 2026
- First submitted
- 19 Apr 2012
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
PubMed 16713924DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.
PubMed 1695404Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
PubMed 1695401
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation Surgery for Movement Disorders
- ClinicalTrials.gov ID
- NCT01581580
- Acronym / sponsor ID
- 110211
- Conditions
- Parkinson's Disease, Essential Tremor, Dystonia
- Keywords
- Parkinson's Disease, Deep Brain Stimulation, Neurophysiology, Movement Disorder, Dystonia, Parkinson Disease, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 17 Aug 2011 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 20 Apr 2012 (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.
Background:
- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.
Objectives:
- To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.
- To obtain information on brain and nerve cell function during DBS surgery.
Eligibility:
- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.
Design:
- Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.
- During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.
- After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.
- Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.
Detailed description
Objective:
The objective of this protocol is to collect prospective physiology data related to DBS therapy and motor and cognitive function in people with medically refractory Parkinson's disease (PD), dystonia, and essential tremor (ET). All treatment under this protocol will be based on the current standard of care for DBS surgery.
Study Population:
Patients 18 years and older with medically refractory PD, dystonia and/or ET may participate in this study.
Study Design:
The treatment that is rendered in this protocol is standard of care for PD, dystonia, and ET. Patients confirmed to have medically refractory PD, dystonia or ET will be offered DBS. The therapeutic goal of this procedure is to implant chronically stimulating macroelectrodes in the basal ganglia or thalamic nuclei in order to alleviate the symptoms of PD, dystonia or ET. Pre- and post-operative imaging will be used to precisely localize electrode locations within the brain and will be correlated with measures of clinical efficacy and recorded intra-operative neural activity. Intra-operative microelectrode recordings, as well as micro- and macroelectrode electrical stimulation, will be used to confirm positioning of electrode leads. Intra-operative electrode recordings will also be used to investigate the neurophysiological mechanisms of deep brain stimulation and to explore the neural circuits underlying motor and cognitive processing in the basal ganglia. Intraoperative physiology will be used for clinical and research purposes. Patients will be followed for 3 months after the surgical procedure to determine effectiveness of DBS treatment.
Outcome Measures:
The primary goal of this protocol is to characterize motor and cognitive function in people receiving standard of care DBS surgery for movement disorders. Secondary measures include 1) radiographic correlation of DBS electrode position and clinical changes; and 2) neurophysiological mechanisms of DBS and motor and cognitive function in the basal ganglia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Other | Device: Medtronic Activa Tremor Control System, Procedure: Deep Brain Stimulationpatients with Parkinson's Disease, dysonia, and essential tremor |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be 18 years of age or older.
- Able to provide informed consent.
- Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:
- idiopathic PD not adequately controlled with medication or
- primary dystonia that is medically refractory, or
Key exclusion criteria (2 listed)
- Are unable or unwilling to give informed consent to the research procedures.
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 |
|---|---|---|
| Medtronic Activa Tremor Control SystemMedtronic DBS Therapy delivers electrical stimulation to an area in the brain to help treat Parkinson's Disease, dystonia, and essential tremor. | Device | treatment arm |
| Deep Brain Stimulationstandard of care DBS surgery for patients with Parkinson's Disease, dystonia, and essential tremor | Procedure or surgery | treatment arm |
Primary outcome
physiology and efficacy of DBS surgery for movement disorders
Time frame: 3 months
change in UPDRS III scale, Burke-Fahn-Marsden (BFM) scale, and Tremor Rating Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 16713924de Lau LM, Breteler MM. Epidemiology of Parkinson's disease. Lancet Neurol. 2006 Jun;5(6):525-35. doi: 10.1016/S1474-4422(06)70471-9.
- Background: PubMed 1695404DeLong MR. Primate models of movement disorders of basal ganglia origin. Trends Neurosci. 1990 Jul;13(7):281-5. doi: 10.1016/0166-2236(90)90110-v.
- Background: PubMed 1695401Alexander GE, Crutcher MD. Functional architecture of basal ganglia circuits: neural substrates of parallel processing. Trends Neurosci. 1990 Jul;13(7):266-71. doi: 10.1016/0166-2236(90)90107-l.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Kareem A Zaghloul, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson's Disease and Essential Tremor, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon C Park ((301) 496-2921, sharon.park@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiology and efficacy of DBS surgery for movement disorders (time frame: 3 months). 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 NCT01581580, which also lists 3 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 26 Oct 2026.