ParkinsonPhase 1NCT02235792
High Frequency Oscillations in Neurologic Disease
A Phase 1 study testing Activa PC+S in people with Parkinson and Epilepsy, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Activa PC+S
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 20 Nov 2020
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically-refractory neurologic disease amenable to therapy with deep brain stimulation including:
- Idiopathic Parkinson disease with motor fluctuation, dyskinesia, and/or medically refractory tremor despite optimal medical management by a movement disorders neurologist.
- OR
- Unilateral or bilateral mesial temporal lobe (hippocampal) epilepsy with complex partial, and/or secondarily generalized seizures, that is:
- confirmed through a combination of interictal scalp EEG, ictal scalp EEG under video monitoring, ictal SPECT scanning, and/or invasive EEG monitoring
- disabling seizure counts >2 per month documented over a 3 month period
Show all 11Show fewer
- refractory to at least three antiepileptic drugs given at clinically appropriate maintenance doses resulting in therapeutic plasma levels (in cases where such levels have been established for that particular drug. Drug failures because of side- effects will not be counted toward this total.
- determined to have mesial temporal lobe epilepsy that is not amenable to resective surgery according to consensus opinion among epileptologists on our institution's multidisciplinary Epilepsy Surgery Committee
- Mayo Clinic Deep Brain Stimulation Committee approval for bilateral deep brain stimulation therapy obtained on routine clinical grounds and without reference to this protocol.
- Age 18 to 75.
- Ability and willingness to provide informed consent and participate in the study protocol.
Who cannot join
- Diagnoses other than those included in #1 above.
- Comorbid nonepileptic behavioral events or psychogenic movement disorder.
- Medical contraindications to DBS surgery.
- Psychiatric comorbidities not under stable medical therapy.
- Neurodegenerative dementia (cognitive dysfunction resulting from frequent seizure activity will not be an exclusion criteria).
- Implanted electronically active medical device with the potential to interfere with intracranial recordings (ex. pacemaker, automatic implantable cardioverter defibrillator (AICD), active vagal nerve stimulator).
- Pregnancy; women of child-bearing potential will be required to commit to using an effective method of contraception during the entire duration of the trial. If a subject becomes pregnant despite these precautions, she will be required to report that to our center within two weeks at which point explantation of the experimental device would be an option.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS).
Read the detailed description
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ability to record brain signals.
- Being tested
- Activa PC+S
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activa PC+SDevice
The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation 37604 Activa PC+S | Experimental | All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study). Receives: Device: Activa PC+S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables.
HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band.
Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects.
(Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.)
Measured: 26 weeks post deep brain stimulator implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2014
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryan T. Klassen, M.D., Mayo Clinic
- Investigators
- Bryan Klassen, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235792
- Sponsor's protocol ID
- 13-002360
- Status last verified
- Apr 2022
- First submitted
- 14 Jul 2014
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Gompel JJ, Klassen BT, Worrell GA, Lee KH, Shin C, Zhao CZ, Brown DA, Goerss SJ, Kall BA, Stead M. Anterior nuclear deep brain stimulation guided by concordant hippocampal recording. Neurosurg Focus. 2015 Jun;38(6):E9. doi: 10.3171/2015.3.FOCUS1541.
PubMed 26030709
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.
- ClinicalTrials.gov ID
- NCT02235792
- Acronym / sponsor ID
- 13-002360
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 10 Sep 2014 (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.
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS).
Detailed description
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ability to record brain signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation 37604 Activa PC+S | Experimental | Device: Activa PC+SAll subjects will undergo DBS using the 37604 Activa PC+S device (single arm study). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Medically-refractory neurologic disease amenable to therapy with deep brain stimulation including:
- OR
- Mayo Clinic Deep Brain Stimulation Committee approval for bilateral deep brain stimulation therapy obtained on routine clinical grounds and without reference to this protocol.
- Age 18 to 75.
- Ability and willingness to provide informed consent and participate in the study protocol.
Key exclusion criteria (7 listed)
- Diagnoses other than those included in #1 above.
- Comorbid nonepileptic behavioral events or psychogenic movement disorder.
- Medical contraindications to DBS surgery.
- Psychiatric comorbidities not under stable medical therapy.
- Neurodegenerative dementia (cognitive dysfunction resulting from frequent seizure activity will not be an exclusion criteria).
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 |
|---|---|---|
| Activa PC+SThe model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain. | Device | Deep Brain Stimulation 37604 Activa PC+S |
Primary outcome
Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
Time frame: 26 weeks post deep brain stimulator implantation
Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables. HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band. Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects. (Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.)
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 15 Apr 2022.
- Derived from this study: PubMed 26030709Van Gompel JJ, Klassen BT, Worrell GA, Lee KH, Shin C, Zhao CZ, Brown DA, Goerss SJ, Kall BA, Stead M. Anterior nuclear deep brain stimulation guided by concordant hippocampal recording. Neurosurg Focus. 2015 Jun;38(6):E9. doi: 10.3171/2015.3.FOCUS1541.
- Mayo Clinic Clinical TrialsLink 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.
Bryan Klassen, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Activa PC+S in people with Parkinson and Epilepsy, run by Mayo Clinic 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 11 inclusion and 7 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 15 Apr 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis (time frame: 26 weeks post deep brain stimulator implantation). 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 NCT02235792, which also lists 1 linked publication.
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 15 Apr 2022.