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Completed

NCT Number: NCT04333511

Brain Stimulation for Patients With Parkinson Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TPS (NEUROLITH)

Device

6 treatments of TPS over 2 weeks

Sham-TPS (NEUROLITH)

Device

6 treatments of Sham-TPS over 2 weeks

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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

  4. 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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).

Sponsors and collaborators

Lead sponsor

Storz Medical AG

Industry

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Oct 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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