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Parkinson DiseaseTOPSNCT04390867

Temporally Optimized Patterned Stimulation (TOPS®) Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

A study testing TOPS1 DBS, TOPS2 DBS and TOPS3 DBS in people with Parkinson Disease, run by Deep Brain Innovations LLC at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
TOPS1 DBS, TOPS2 DBS and TOPS3 DBS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
3 sitesUnited States
Study dates
27 Jul 2020to 8 Feb 2022
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with Parkinson's disease
  • Implanted with unilateral or bilateral subthalamic DBS System to treat Parkinson's disease at least 6 months prior to the study date
  • Responds to DBS by having demonstrated a minimum improvement in motor score

Who cannot join

  • Score of <24 on the Mini Mental Status Exam
  • Abuses drugs or alcohol
  • Pregnant
  • History of significant cardiovascular, pulmonary, musculoskeletal, metabolic, or other neurological disorders (i.e. epilepsy, stroke)
  • Prisoners, employees that report to investigators

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Duke University

    Durham, North Carolina, 27705

  • University of Florida

    Gainesville, Florida, 32608

Other trials in United States

About this study

Official title: A Prospective, Randomized, Cross-Over Home-Use Study of TOPS® DBS for the Treatment of Parkinson's Disease

This study will test newly developed stimulation settings called Temporally Optimized Patterned Stimulation or TOPS, which can be used with an already implanted deep brain stimulation system. The purpose of this study is to determine if TOPS DBS can improve Parkinson's symptoms compared to Standard DBS.

Being tested
TOPS1 DBS, TOPS2 DBS, TOPS3 DBS, Standard DBS
Keywords
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.

  • TOPS1 DBSDevice

    TOPS1 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system

  • TOPS2 DBSDevice

    TOPS2 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system

  • TOPS3 DBSDevice

    TOPS3 is an investigational novel pattern of stimulation that is programmed non-invasively into an already implanted DBS system

  • Standard DBSDevice

    Standard is the pattern of stimulation that is usually delivered clinically by a DBS system

Study groups in NCT04390867
Study groupRoleWhat they receive
TOPS1 DBSExperimentalParticipants receive TOPS1 for one week if it meets screening criteria, followed by one week each of TOPS2, TOPS3, and Standard in random order.
Receives: Device: TOPS1 DBS; Device: TOPS2 DBS; Device: TOPS3 DBS; Device: Standard DBS
TOPS2 DBSExperimentalParticipants receive TOPS2 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS3, and Standard in random order.
Receives: Device: TOPS1 DBS; Device: TOPS2 DBS; Device: TOPS3 DBS; Device: Standard DBS
TOPS3 DBSExperimentalParticipants receive TOPS3 for one week if it meets screening criteria, followed by one week each of TOPS1, TOPS2, and Standard in random order.
Receives: Device: TOPS1 DBS; Device: TOPS2 DBS; Device: TOPS3 DBS; Device: Standard DBS
Standard DBSActive comparatorParticipants receive Standard for one week, followed by one week each of TOPS1, TOPS2, and TOPS3 in random order.
Receives: Device: TOPS1 DBS; Device: TOPS2 DBS; Device: TOPS3 DBS; Device: Standard DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS

    Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms.

    Measured: After 1 week treatment period using each pattern

  2. Study related adverse device effects

    Reported AEs

    Measured: After 1 week treatment period using TOPS1

  3. Study related adverse device effects

    Reported AEs

    Measured: After 1 week treatment period using TOPS2

  4. Study related adverse device effects

    Reported AEs

    Measured: After 1 week treatment period using TOPS3

  5. Study related adverse device effects

    Reported AEs

    Measured: After 1 week treatment period using Standard

Secondary outcomes (10)

  1. Home Use "On Time"

    Home use Parkinson's disease motor symptom diary recording On Time without dyskinesia, On Time with non-troublesome dyskinesia, On Time with troublesome dyskinesia, Off Time, and Asleep Time. Average "On Time" difference between the best TOPS and Standard

    Measured: During 1 week treatment period using each pattern

  2. Patient Global Impression of Improvement Rating

    Average difference in PGII between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse

    Measured: After 1 week treatment period using each pattern

  3. Parkinson's Medication Use

    Parkinson's medication usage recorded in home use medication diary. Average difference between the best TOPS and Standard

    Measured: During 1 week treatment period using each pattern

  4. Rest Tremor - Off medication/On DBS

    Measured using Kinesia One system. Average difference between the best TOPS and Standard

    Measured: After 1 week treatment period using each pattern

  5. Postural Tremor - Off medication/On DBS

    Measured using Kinesia One system. Average difference between the best TOPS and Standard.

    Measured: After 1 week treatment period using each pattern

  6. Bradykinesia - Off medication/On DBS

    Measured using Kinesia One system. Average difference between the best TOPS and Standard.

    Measured: After 1 week treatment period using each pattern

  7. Type and severity of side effects of stimulation

    Proportion of participants experiencing side effects recorded in home use motor symptom diary and clinic. Average difference between the best TOPS and Standard

    Measured: During 1 week treatment period using each pattern

  8. Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - On medication/On DBS

    Average difference between the best TOPS and Standard. The MDS-UPDRS Part III is the sum of 33 scores evaluating a set of Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicates no symptom is present and a maximum score of 4 indicates the most severe symptom. The total scale range is 0-132, where higher scores indicate more severe symptoms.

    Measured: After 1 week treatment period using each pattern

  9. Clinical Global Impression of Improvement Rating

    Average difference in CGII score between the best TOPS and Standard. Improvement is scored on a scale of 1 - 7 where 1 is Very Much Improved and 7 is Very Much Worse

    Measured: After 1 week treatment period using each pattern

  10. Test Pattern Use Count

    For each pattern, the number of subjects who go home with it and use it for the entire test period (~7-14 days) will be counted to evaluate if any patterns are more or less likely to be skipped

    Measured: After 1 week treatment period using each pattern

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start27 Jul 2020
  3. Primary completion2 Feb 2022
  4. Study completion8 Feb 2022

Why it stopped: Business decision on June 2, 2022

Resources

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
Crossover
Model description
Random order of presentation of all three TOPS and Standard DBS in each participant
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04390867
Sponsor's protocol ID
0152
Acronym
TOPS
Status last verified
Sep 2021
First submitted
4 May 2020
Last updated
27 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TOPS1 DBS, TOPS2 DBS and TOPS3 DBS in people with Parkinson Disease, run by Deep Brain Innovations LLC at 3 sites 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 3 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: stopped early, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

The study was stopped early (reason given: Business decision on June 2, 2022). Results are not available in the source record.

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?

Movement Disorders Society-Unified Parkinson's Disease Rating Scale Part III Motor score - Off medication/On DBS (time frame: After 1 week treatment period using each pattern). The study lists 5 primary outcomes in all. 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 NCT04390867.

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 27 Jun 2022.

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TOPS Clinical Trial NCT04390867 | AzTrials