Brain Stimulation for Patients With Parkinson Disease

NCT04333511 | Completed

• 1 other identifier: STU 14/032
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (14)

• Activities of daily living (ADL)

  Immediately post-treatment

• Activities of daily living (ADL)

  1 month post-treatment

• Anatomical and Functional Magnetic Resonance Imaging (3 Tesla MRI)

  Immediately post-treatment

• Somatosensory evoked EEG Potentials (SEPs)

  Immediately post-stimulation

• Bayer Activities of Daily Living Scale (B-ADL)

  Immediately post-treatment

Study Arms (2)

Sequence 1

EXPERIMENTAL

TPS first with crossover to Sham-TPS

Device: TPS (NEUROLITH); Device: Sham-TPS (NEUROLITH)

Sequence 2

EXPERIMENTAL

Sham-TPS first with crossover to TPS

Device: TPS (NEUROLITH); Device: Sham-TPS (NEUROLITH)

Interventions

TPS (NEUROLITH) DEVICE

6 treatments of TPS over 2 weeks

Sequence 1; Sequence 2

Sham-TPS (NEUROLITH) DEVICE

6 treatments of Sham-TPS over 2 weeks

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Storz Medical AG: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related 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.

  PMID: 20659452 BACKGROUND

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

  PMID: 19802812 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roland Beisteiner, Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: December 2, 2019
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)