Brain Stimulation for Patients With Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Brain Stimulation for Patients With Parkinson Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333511
• Other study ID #: STU 14/032
• Status: Completed
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: August 3, 2022

Study information

• Verified date: September 2022
• Source: Storz Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• TPS (NEUROLITH)
6 treatments of TPS over 2 weeks
• Sham-TPS (NEUROLITH)
6 treatments of Sham-TPS over 2 weeks

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Storz Medical AG

Country where clinical trial is conducted

Austria, 

References & Publications (2)

Foki T, Pirker W, Klinger N, Geissler A, Rath J, Steinkellner T, Hoellinger I, Gruber S, Haubenberger D, Lehrner J, Pusswald G, Trattnig S, Auff E, Beisteiner R. FMRI correlates of apraxia in Parkinson's disease patients OFF medication. Exp Neurol. 2010 Oct;225(2):416-22. doi: 10.1016/j.expneurol.2010.07.019. Epub 2010 Jul 24. — View Citation

Perlmutter JS. Assessment of Parkinson disease manifestations. Curr Protoc Neurosci. 2009 Oct;Chapter 10:Unit10.1. doi: 10.1002/0471142301.ns1001s49. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor manifestations of Parkinson Disease	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
Primary	Motor manifestations of Parkinson Disease	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
Primary	Manual dexterity	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
Primary	Manual dexterity	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	Activities of daily living (ADL)	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
Secondary	Activities of daily living (ADL)	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
Secondary	Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)	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
Secondary	Somatosensory evoked EEG Potentials (SEPs)	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
Secondary	Bayer Activities of Daily Living Scale (B-ADL)	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
Secondary	Bayer Activities of Daily Living Scale (B-ADL)	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
Secondary	Leisure Behavior (FZV; German: Freizeitverhalten)	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
Secondary	Leisure Behavior (FZV; German: Freizeitverhalten)	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
Secondary	Montreal Cognitive Assessment (MOCA)	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
Secondary	Montreal Cognitive Assessment (MOCA)	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
Secondary	Geriatric Depression Scale - short form (GDS-15)	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
Secondary	Geriatric Depression Scale - short form (GDS-15)	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
Secondary	Beck Depression Inventory (BDI)	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
Secondary	Beck Depression Inventory (BDI)	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