Parkinson DiseaseFREQUENCYNCT03800108

Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS

A study testing Personalized DBS adjustments in people with Parkinson Disease, run by Darlene Floden at 1 site 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 evaluates the role of subthalamic nucleus (STN) stimulation location and frequency on a range of cognitive processes in Parkinson's patients who have undergone Deep Brain Stimulation (DBS). Read more about this study

Who is it for?: Ages 40 to 70 years
Conditions the study is for: Parkinson Disease
What is being tested?: Personalized DBS adjustments
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 30 May 2018to 14 Jan 2020
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 40 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Between 40 and 70 years of age,
Ability to provide informed consent,
Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
Disease duration of at least 4 years,
Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Who cannot join

History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine),
Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
Current alcohol or substance abuse,
Lack of fluency in English which would invalidate cognitive testing,
Hearing or visual impairment precluding cognitive testing.
Inability to safely undergo MRI procedure (i.e., metal objects like prostheses, pacemakers)

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

Read the detailed description

Pre- and post- DBS implantation brain scans will be reviewed by the study team to see if patients' DBS settings can be personalized. If so, study subjects will undergo adjustments to their DBS settings and be asked to perform cognitive tests. Some patients will be asked to come back for a second visit for brain scans.

Conditions: Parkinson Disease
Being tested: Personalized DBS adjustments
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Personalized DBS adjustmentsProcedure or surgery
Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Study groups in NCT03800108
Study group	Role	What they receive
Personalized DBS adjustments	Other	Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs Receives: Procedure: Personalized DBS adjustments

What is being measured

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

Reaction Time
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Measured: 30-60 minutes after stimulation adjustment
Verbal Fluency
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Measured: 30-60 minutes after stimulation adjustment
Finger Tapping Speed
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'
Measured: 30-60 minutes after stimulation adjustment

Timeline

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

30 May 201814 Jan 2020

First posted11 Jan 2019
Study start30 May 2018
Primary completion14 Jan 2020
Study completion14 Jan 2020

Why it stopped: The study was stopped early due to insufficient staff to continue EEG data collection and analysis following the departure of key study personnel.

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.
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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03800108
Sponsor's protocol ID: 17-1350
Acronym: FREQUENCY
Status last verified: Feb 2025
First submitted: 23 May 2018
Last updated: 5 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Stimulation Parameters and Non-motor Symptoms in PD Treated With DBS
ClinicalTrials.gov ID: NCT03800108
Acronym / sponsor ID: FREQUENCY / 17-1350
Conditions: Parkinson Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped early due to insufficient staff to continue EEG data collection and analysis following the departure of key study personnel.
Enrolment: 5 participants (actual)
Lead sponsor: Darlene FlodenUniversity, hospital or other
Study start: 30 May 2018 (actual)
Primary completion: 14 Jan 2020 (actual)
Study completion: 14 Jan 2020 (actual)
First posted: 11 Jan 2019 (actual)
Results: Posted 5 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Personalized DBS adjustments	Other	Procedure: Personalized DBS adjustmentsIndividualized stimulation adjustments based on pre- and post- DBS implantation MRIs

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Between 40 and 70 years of age,
Ability to provide informed consent,
Clinical diagnosis of idiopathic Parkinson disease (PD) by a movement disorders neurologist,
Disease duration of at least 4 years,
Treated with bilateral STN DBS for at least 3 months prior to study enrollment.

Key exclusion criteria (8 listed)

History of prior neurosurgical intervention for PD (e.g., DBS, thalamotomy, pallidotomy)
History of other central nervous system disease (excluding migraine),
Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation, with the exception of mild depression (Beck Depression Inventory-2 score below 19),
Cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation,
Current alcohol or substance abuse,

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
Personalized DBS adjustmentsIndividualized stimulation adjustments based on pre- and post- DBS implantation MRIs	Procedure or surgery	Personalized DBS adjustments

Primary outcome

Reaction Time
Time frame: 30-60 minutes after stimulation adjustment
Subjects will complete one or more measures of cognitive processing requiring speeded responses to stimuli. Changes in reaction time will be compared to 'off stimulation'
Verbal Fluency
Time frame: 30-60 minutes after stimulation adjustment
Change in the number words that patients generate to letter or semantic category cues will be compared to 'off stimulation'
Finger Tapping Speed
Time frame: 30-60 minutes after stimulation adjustment
Change in upper extremity speed (# of taps in 10 seconds) will be compared to 'off stimulation'

Results and safety

Results posted to the registry on 5 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Personalized DBS Adjustments	5	5

Primary outcome: Reaction Time

Time frame: 30-60 minutes after stimulation adjustment. Count of participants. Unit: Participants

Measure	Personalized DBS Adjustments n = 3
Inhibitory control worse with Ventral High Hz	2
Inhibitory control worse with Dorsal Low Hz	1

Primary outcome: Verbal Fluency

Time frame: 30-60 minutes after stimulation adjustment. Mean (Full Range). Unit: words

Measure	Personalized DBS Adjustments n = 3
Change at Dorsal High Hz	6.3 (2 to 11)
Change at Ventral Low Hz	-0.3 (-5 to 5)

Population analysed: Patients with Deep Brain Stimulation Electrodes implanted to treat Parkinson's disease

Primary outcome: Finger Tapping Speed

Time frame: 30-60 minutes after stimulation adjustment. Mean (Full Range). Unit: finger taps

Measure	Personalized DBS Adjustments n = 3
Taps change at Dorsal High Hz	2.1 (-1 to 5)
Taps change at Ventral Low Hz	2.2 (.66 to 4.5)

Adverse events

Time frame: Adverse event data were collected for 2-3 days, depending on the number of study sessions, with monitoring by Clinical Research Unit (CRU) nursing staff and the research team. Participants were assessed for safety and well-being after each change in stimulation parameters during EEG recording and fMRI sessions as well as by telephone one day after their final study session.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Personalized DBS Adjustments	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Limitations and caveats (from the sponsor): Limitations of this trial include early termination due to a lack of eligible patients which led to a reduced sample size and limited data collection. This constraint impacted the statistical power and the ability to conduct complete analyses as initially planned. Additionally, technical limitations related to EEG data collection and analysis emerged, as key personnel responsible for EEG recording and data processing were unavailable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
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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.

Darlene Floden, PhD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Personalized DBS adjustments in people with Parkinson Disease, run by Darlene Floden 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 8 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 5 Feb 2025. 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 5 Feb 2025). 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?

Reaction Time (time frame: 30-60 minutes after stimulation adjustment). The study lists 3 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 NCT03800108.

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 5 Feb 2025.