Brain Stimulation for Patients With Parkinson Disease

September 30, 2022 updated by: Storz Medical AG
The aim of this crossover study is to investigate the efficacy of non-invasive brain stimulation (transcranial pulse stimulation; TPS) in adults with Parkinson Disease (PD). Participants will receive 6 sessions of TPS and Sham-TPS, respectively, in random order. Motor manifestations of PD and manual dexterity will be the primary outcome measures. Outcomes will be assessed immediately post-treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically stable PD with fine skilled and/or gross motor deficits (e.g. right arm with a clinical force level >2)
  • Signed written informed consent
  • Monthly pregnancy test for women in childbearing years
  • Age >= 18 years

Exclusion Criteria:

  • Non-compliance with the protocol
  • Pregnant or breastfeeding women
  • Relevant intracerebral pathology unrelated to the disease (e.g. Brain tumor)
  • Hemophilia or other blood clotting disorders
  • Cortisone treatment within the last 6 weeks before first treatment
  • Thrombosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1
TPS first with crossover to Sham-TPS
Device: TPS (NEUROLITH)
6 treatments of TPS over 2 weeks
Device: Sham-TPS (NEUROLITH)
6 treatments of Sham-TPS over 2 weeks
Experimental: Sequence 2
Sham-TPS first with crossover to TPS
Device: TPS (NEUROLITH)
6 treatments of TPS over 2 weeks
Device: Sham-TPS (NEUROLITH)
6 treatments of Sham-TPS over 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Motor manifestations of Parkinson Disease
Time Frame: Immediately post-treatment
Motor manifestations of Parkinson Disease will be rated by an examiner using the relevant subscale (section III) of the Unified Parkinson Disease Rating Scale (UPDRS). This scale has 14 different types of ratings, with many of these ratings done independently for the different limbs (tremor at rest, action tremor, rigidity, bradykinesia, speech, facial expression, arising from a chair, posture, gait, postural stability, body bradykinesia). Each of the ratings ranges from 0 (normal) to 4 (severe manifestation). The total score for this scale ranges from 0 to 108, the sum of scores from 27 observations (Perlmutter 2009).
Immediately post-treatment
Motor manifestations of Parkinson Disease
Time Frame: 1 month post-treatment
Motor manifestations of Parkinson Disease will be rated by an examiner using the relevant subscale (section III) of the Unified Parkinson Disease Rating Scale (UPDRS). This scale has 14 different types of ratings, with many of these ratings done independently for the different limbs (tremor at rest, action tremor, rigidity, bradykinesia, speech, facial expression, arising from a chair, posture, gait, postural stability, body bradykinesia). Each of the ratings ranges from 0 (normal) to 4 (severe manifestation). The total score for this scale ranges from 0 to 108, the sum of scores from 27 observations (Perlmutter 2009).
1 month post-treatment
Manual dexterity
Time Frame: Immediately post-treatment
Deficits in fine skilled movements will be assessed by the coin rotation test (Foki et al., 2010). A coin hast to be flipped with the first 3 fingers of one hand as fast as possible for 30 seconds. The number of successful half rotations will be determined.
Immediately post-treatment
Manual dexterity
Time Frame: 1 month post-treatment
Deficits in fine skilled movements will be assessed by the coin rotation test (Foki et al., 2010). A coin hast to be flipped with the first 3 fingers of one hand as fast as possible for 30 seconds. The number of successful half rotations will be determined.
1 month post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activities of daily living (ADL)
Time Frame: Immediately post-treatment
ADL will be assessed using the relevant subscale (section II) of the UPDRS. The scale consists of 13 items (speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bedclothes, falling (unrelated to freezing), freezing when walking, walking, tremor, sensory complaints related to parkinsonism). The scoring range for each item is from 0 (normal) to 4 (severe impairment). The examiner asks the patient to describe their function separately in the ON and OFF state. The responses for each of the items are therefore scored twice. These ratings are done by the examiner based upon the responses of the patient or caregiver. The total score for subscale 2 ranges from 0 to 56 (Perlmutter 2009).
Immediately post-treatment
Activities of daily living (ADL)
Time Frame: 1 month post-treatment
ADL will be assessed using the relevant subscale (section II) of the UPDRS. The scale consists of 13 items (speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bedclothes, falling (unrelated to freezing), freezing when walking, walking, tremor, sensory complaints related to parkinsonism). The scoring range for each item is from 0 (normal) to 4 (severe impairment). The examiner asks the patient to describe their function separately in the ON and OFF state. The responses for each of the items are therefore scored twice. These ratings are done by the examiner based upon the responses of the patient or caregiver. The total score for subscale 2 ranges from 0 to 56 (Perlmutter 2009).
1 month post-treatment
Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)
Time Frame: Immediately post-treatment
fMRI to analyze brain activation and connectivity. Anatomical data are also used for safety evaluations: to exclude bleeding or anatomical changes of the brain
Immediately post-treatment
Somatosensory evoked EEG Potentials (SEPs)
Time Frame: Immediately post-stimulation
In selected participants, standard EEG / EP (Electroencephalography / Evoked Potential) data will be recorded for procedural optimizations, i.e. evaluation of most promising parameter settings (energy level and pulse frequency).
Immediately post-stimulation
Bayer Activities of Daily Living Scale (B-ADL)
Time Frame: Immediately post-treatment
The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
Immediately post-treatment
Bayer Activities of Daily Living Scale (B-ADL)
Time Frame: 1 month post-treatment
The B-ADL scale is used to assess deficits in the performance of everyday activities. The scale's main target group is community dwelling patients who suffer from mild cognitive impairment or mild-to-moderate dementia. It comprises 25 items. Each item is scored from 1 (no difficulties at all) to 10 (always difficulties). The global B-ADL score is the arithmetic mean of all items.
1 month post-treatment
Leisure Behavior (FZV; German: Freizeitverhalten)
Time Frame: Immediately post-treatment
The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
Immediately post-treatment
Leisure Behavior (FZV; German: Freizeitverhalten)
Time Frame: 1 month post-treatment
The leisure behavior questionnaire has 25 items covering the following activities: information / entertainment, active movement, social interactions, creative activities, church / cultural / educational activities. The frequency of each activity is rated on a Likert-Scale from 0 (never) to 6 (daily). The total score (0-6) is calculated as the average of all 25 items.
1 month post-treatment
Montreal Cognitive Assessment (MOCA)
Time Frame: Immediately post-treatment
The MOCA is a screening instrument for assessing cognitive impairment. It is scored out of 30 (higher scores represent better cognition) and contains sections on visuospatial/executive, naming, memory, attention, language, abstraction, and orientation.
Immediately post-treatment
Montreal Cognitive Assessment (MOCA)
Time Frame: 1 month post-treatment
The MOCA is a screening instrument for assessing cognitive impairment. It is scored out of 30 (higher scores represent better cognition) and contains sections on visuospatial/executive, naming, memory, attention, language, abstraction, and orientation.
1 month post-treatment
Geriatric Depression Scale - short form (GDS-15)
Time Frame: Immediately post-treatment
he Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
Immediately post-treatment
Geriatric Depression Scale - short form (GDS-15)
Time Frame: 1 month post-treatment
he Geriatric Depression Scale (GDS) is a questionnaire to assess depression in the elderly population. This scale generates self-evaluation scores concerning various aspects with relevance for the depressive disease (e.g. mood, drive, anxiety). The short form contains 15 items. The GDS-15 score ranges from 0 (normal state) to 15 (severe depression).
1 month post-treatment
Beck Depression Inventory (BDI)
Time Frame: Immediately post-treatment
BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
Immediately post-treatment
Beck Depression Inventory (BDI)
Time Frame: 1 month post-treatment
BDI stands for the "Beck Depression Inventory". The Beck Depression Inventory (BDI) measures the severity of depression (Beck 1961). It is a 21-item questionnaire for self-evaluation with 0-3 scores per item. The total score is the sum of all items. It ranges from 0 (normal state) to 63 (severe depression).
1 month post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Storz Medical AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Roland Beisteiner, Prof., Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU 14/032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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