Basal Ganglia DiseasesNCT01905995
Basal Ganglia Local Field Potentials in Gait and Speech
An observational study of Basal Ganglia Diseases, run by Kai Bötzel at 1 site in Germany.
Trial summary
Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc). Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Basal Ganglia Diseases
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced Parkinson's disease
Who may be able to join
- good levodopa response
Who cannot join
- dementia
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Dept. of Neurology, Ludwig-Maximilians University of Munich
Munich/München
Kai Bötzel, M.D., 0049 89 7095 3673, kboetzel@med.uni-muenchen.de
Kai Bötzel, M.D.
About this study
Official title: Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease
Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc).
Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.
- Conditions
- Basal Ganglia Diseases
- Keywords
- deep brain sitimulation, local field potentials
- Medical subject headings
- Basal Ganglia Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with advanced Parkinson's disease | no intervention - observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of frequency spectrum of basal ganglia local field potentials during gait and speech
Measured: 1 year
Secondary outcomes (1)
Evidence for the benefit of different stimulator settings for gait and speech
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Ganglia DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Bötzel
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Lueneburg Heritage
- Responsible party
- Sponsor-investigator, Kai Bötzel, Ludwig-Maximilians - University of Munich
- Investigators
- Kai Bötzel, M.D., Principal investigator, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905995
- Sponsor's protocol ID
- BG EEG Munich
- Status last verified
- Jul 2013
- First submitted
- 19 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recording of Gait and Speech Related Neurophysiological Parameters With an Implantable Bi-directional Deep Brain Stimulation System in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01905995
- Acronym / sponsor ID
- BG EEG Munich
- Conditions
- Basal Ganglia Diseases
- Keywords
- deep brain sitimulation, local field potentials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Kai BötzelUniversity, hospital or other
- Collaborators
- Medtronic, Lueneburg Heritage
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 23 Jul 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.
Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc).
Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with advanced Parkinson's disease | – | –no intervention - observational study |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced Parkinson's disease
Key inclusion criteria (1 listed)
- good levodopa response
Key exclusion criteria (1 listed)
- dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of frequency spectrum of basal ganglia local field potentials during gait and speech
Time frame: 1 year
1 secondary outcome
Evidence for the benefit of different stimulator settings for gait and speech
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
Related trials for Basal Ganglia Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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.
Kai Bötzel, M.D. principal investigator
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Ganglia Diseases, run by Kai Bötzel at 1 site in Germany.
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 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. 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 Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Boetzel, M.D (00498970953673, kboetzel@med.uni-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of frequency spectrum of basal ganglia local field potentials during gait and speech (time frame: 1 year). 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 23 Jul 2013.