Parkinson DiseaseNCT00360009
Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
A study testing DBS of the STN and DBS of the GPI in people with Parkinson Disease, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DBS of the STN and DBS of the GPI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Apr 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intractable, disabling PD with motor fluctuations, dyskinesias, or freezing episodes
- Age between 30-75 years
- Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-Parkinsonian drugs)
- A stable and optimal medical regimen of anti-Parkinsonian drug therapy for at least three months prior to surgery
- Patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.
Who cannot join
- Clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
- Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
- MRI scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
- The Mattis Dementia Rating Scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
- A major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Medicine, Department of Neurology, McKnight Brain Institute, 100 South Newell Drive, L-3 100
Gainesville, Florida, 32610-0236
About this study
Official title: Cognition and Mood in Parkinson's Disease (PD) in Subthalamic Nucleus (STN) Versus Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
The purpose of this trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.
Read the detailed description
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, and bradykinesia. However, there is increasing evidence that DBS may be associated with a significant number of mood and cognitive changes.
The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi, to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas, and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition.
In the study, researchers will compare motor, mood, and cognitive function in people with PD who have had DBS treatment with control subjects (or individuals with PD who have not had DBS). The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target (STN and GPi), compare the targets, and examine the role of lead location.
The study will enroll 62 participants-10 control subjects (individuals with PD who have not had DBS), and 52 individuals with PD who are scheduled for DBS; the site of the implant (STN or GPi) will be randomly assigned. Participants will perform motor, mood, and cognitive tests (following 6 months of stimulation) over a 2-day period. Duration of the trial for participants is 6 months and includes a 2-night hospital stay.
Findings from this study may help researchers better understand how DBS affects non-motor circuitry.
- Conditions
- Parkinson Disease
- Being tested
- DBS of the STN, DBS of the GPI
- Keywords
- Parkinson's disease, Parkinson disease, PD, deep brain stimulation, DBS, subthalamic nucleus, STN, globus pallidus interna, GPi, mood, motor symptoms, cognition, emotion, memory, attention, tremor, rigidity, bradykinesia
- Medical subject headings
- Parkinson Disease, Tremor, Muscle Rigidity, Hypokinesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS of the STNProcedure or surgery
Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.
DBS of the GPIProcedure or surgery
Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.
| Study group | Role | What they receive |
|---|---|---|
| STN DBS | Active comparator | Patients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's disease (PD) Receives: Procedure: DBS of the STN |
| GPI DBS | Active comparator | Patients who underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) to treat Parkinson's disease (PD) Receives: Procedure: DBS of the GPI |
| no DBS | No intervention | non-DBS PD patient control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Afraid State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Confused State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Energetic State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Happy State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Sad State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Tense State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Visual Analogue Mood Scales (VAMS) Tired State
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Secondary outcomes (3)
Change in Spielberger State-Trait Anxiety Inventory (STAI)
STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-1.4) indicates a reduction in anxiety from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in anxiety. The larger the absolute T-score value,the greater the mean change in anxiety.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Beck Depression Inventory (BDI)
BDI is a questionnaire used to measure depression. There is a four-point scale for each of the 21-items of the questionnaire with scores ranging from 0 to 3. Total raw scores range from 0 to 63. The higher the score the greater the severity of depression. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-3.7) indicates a reduction in depression from pre to post-DBS while a positive T-score difference (0.4) denotes an increase in depression. The larger the absolute T-score value,the greater the mean change in depression.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Change in Letter Fluency Tasks (LFT)
LFT assess frontal lobe function. Performance measure is number of words beginning with a specific letter generated in 1 min. Although no range of possible scores,the more words named in allotted time,the higher the predicted frontal lobe function. Raw score is converted to T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-2.6) signifies a reduction in task performance from pre to post-DBS while a positive T-score difference(0.7) denotes an increase in task performance. The larger the absolute T-score value,the greater the mean change in performance.
Measured: Pre-surgery baseline to 6 months of DBS stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2006 (estimated)
- Study startJan 2004
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Okun, MD, Principal investigator, University of FloridaKelly Foote, MD, Principal investigator, University of FloridaHubert Fernandez, MD, Principal investigator, University of FloridaRamon Rodriguez, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00360009
- Sponsor's protocol ID
- 303-2002
- Other IDs
- K23NS044997
- Status last verified
- Oct 2012
- First submitted
- 2 Aug 2006
- Last updated
- 31 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition and Mood in Parkinson's Disease (PD) in Subthalamic Nucleus (STN) Versus Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)
- ClinicalTrials.gov ID
- NCT00360009
- Acronym / sponsor ID
- 303-2002
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Parkinson disease, PD, deep brain stimulation, DBS, subthalamic nucleus, STN, globus pallidus interna
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jan 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 3 Aug 2006 (estimated)
- Results
- Posted 2 Feb 2010
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 trial is to study the mood and cognitive effects of deep brain stimulation in Parkinson's disease.
Detailed description
Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as tremor, rigidity, and bradykinesia. However, there is increasing evidence that DBS may be associated with a significant number of mood and cognitive changes.
The aims of this study are to characterize and compare the mood and cognitive effects associated with DBS of the STN and GPi, to delineate regions within or around the STN and GPi that are associated with specific mood and cognitive changes when DBS is applied to these areas, and to assess the relative effectiveness of right versus left STN or GPi stimulation on mood and cognition.
In the study, researchers will compare motor, mood, and cognitive function in people with PD who have had DBS treatment with control subjects (or individuals with PD who have not had DBS). The scientists will characterize the types and incidence of mood and cognitive changes that occur during DBS in each target (STN and GPi), compare the targets, and examine the role of lead location.
The study will enroll 62 participants-10 control subjects (individuals with PD who have not had DBS), and 52 individuals with PD who are scheduled for DBS; the site of the implant (STN or GPi) will be randomly assigned. Participants will perform motor, mood, and cognitive tests (following 6 months of stimulation) over a 2-day period. Duration of the trial for participants is 6 months and includes a 2-night hospital stay.
Findings from this study may help researchers better understand how DBS affects non-motor circuitry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STN DBS | Active comparator | Procedure: DBS of the STNPatients who underwent deep brain stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's disease (PD) |
| GPI DBS | Active comparator | Procedure: DBS of the GPIPatients who underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) to treat Parkinson's disease (PD) |
| no DBS | No intervention | –non-DBS PD patient control group |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Intractable, disabling PD with motor fluctuations, dyskinesias, or freezing episodes
- Age between 30-75 years
- Unsatisfactory clinical response to maximal medical management (with trials of both higher and lower doses of anti-Parkinsonian drugs)
- A stable and optimal medical regimen of anti-Parkinsonian drug therapy for at least three months prior to surgery
- Patients must be right-handed to be included in the study since mood and cognition are being analyzed and right hemisphere dominant patients could confound the results.
Key exclusion criteria (5 listed)
- Clinically significant medical disease that would increase risk of developing pre- or postoperative complications (e.g., significant cardiac or pulmonary disease, uncontrolled hypertension)
- Evidence of secondary or atypical parkinsonism as suggested by the presence of any of the following: 1) history of stroke(s), 2) exposure to toxins or neuroleptics, 3) history of encephalitis, 4) neurological signs of upper motor neuron disease, cerebellar involvement, supranuclear gaze palsy, or significant orthostatic hypotension
- MRI scan with significant evidence of brain atrophy or other abnormalities (e.g., lacunar infarcts or iron deposits in the putamen)
- The Mattis Dementia Rating Scale will be used to assess the level of intellectual function and patients will be excluded with scores reflecting clinical dementia
- A major psychiatric disorder on the Structured Clinical Interview for DSM-IV (SCID-IV).
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 |
|---|---|---|
| DBS of the STNPatients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device. | Procedure or surgery | STN DBS |
| DBS of the GPIPatients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device. | Procedure or surgery | GPI DBS |
Primary outcome
Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Afraid State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Confused State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Energetic State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Happy State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Sad State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Tense State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
Change in Visual Analogue Mood Scales (VAMS) Tired State
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
VAMS measure mood states using scales that have a neutral face/word at the top of a vertical line and a specific mood face/word at the bottom of the line. Respondents indicate a point on the line that describes how they are feeling and a raw score between 0-100 is obtained. The raw score is converted to a T-score. The mean pre and post-DBS T-scores are compared. A negative difference in T-score(-0.5) indicates a reduction in mood from pre to post-DBS while a positive T-score difference(2.4) denotes an increase in mood. The larger the absolute T-score value, the greater the mean change in mood.
3 secondary outcomes
Change in Spielberger State-Trait Anxiety Inventory (STAI)
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
Change in Beck Depression Inventory (BDI)
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
Change in Letter Fluency Tasks (LFT)
Time frame: Pre-surgery baseline to 6 months of DBS stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Okun, MD principal investigator
University of Florida
Kelly Foote, MD principal investigator
University of Florida
Hubert Fernandez, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS of the STN and DBS of the GPI in people with Parkinson 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 5 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: finished, as of the sponsor's last update on 31 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 2 Feb 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean T-score of Visual Analogue Mood Scales (VAMS) Angry State (time frame: Pre-surgery baseline to 6 months of DBS stimulation). The study lists 8 primary outcomes in all. 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 31 Oct 2012.