Brain Stimulation for Neurological Patients

NCT03770182 | Completed

• 1 other identifier: TPS-AD-Vienna
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective double-blind randomized placebo-controlled crossover clinical trial

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Consortium to Establish a Registry for Alzheimer's Disease (CERAD) - Corrected Total Score

  CERAD stands for "The Consortium to Establish a Registry for Alzheimer's Disease". The CERAD was funded by the National Institute on Aging in 1986 to develop standardized, validated measures for the assessment of Alzheimer's disease (Fillenbaum 2008). CERAD is a cognitive test battery which is normalized for age, gender and education (Morris 1988). The CERAD total score (Chandler 2005) is a good measure for Alzheimer's Disease (Ehrensperger 2010, Rossetti 2010, Seo 2010, Hallikainen 2013). The CERAD total score is a scale from 0 to 100 with 100 meaning "normal cognitive ability" and 0 meaning "severe cognitive impairment".

  month 3

Secondary Outcomes (41)

• Alzheimer's Disease Assessment Scale (ADAS)

  immediately post-treatment

• Alzheimer's Disease Assessment Scale (ADAS)

  month 1

• Alzheimer's Disease Assessment Scale (ADAS)

  month 3

• Neuropsychological Test Battery Vienna (NTBV)

  immediately post-treatment

• Neuropsychological Test Battery Vienna (NTBV)

  month 1

Study Arms (2)

Group A

EXPERIMENTAL

NEUROLITH * Cycle 1: Active treatment * Cycle 2: Sham treatment

Device: NEUROLITH

Group B

EXPERIMENTAL

NEUROLITH * Cycle 1: Sham treatment * Cycle 2: Active treatment

Device: NEUROLITH

Interventions

NEUROLITH DEVICE

transcranial pulse stimulation (TPS)

Also known as: transcranial pulse stimulation, TPS

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically stable patients with probable Alzheimer's Disease (Diagnosis according to ICD-10 Criteria (F00))
• At least 3 months of stable antidementive therapy or no antidementive therapy necessary
• 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 Alzheimers's 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
• Medical University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related Publications (20)

• Chandler MJ, Lacritz LH, Hynan LS, Barnard HD, Allen G, Deschner M, Weiner MF, Cullum CM. A total score for the CERAD neuropsychological battery. Neurology. 2005 Jul 12;65(1):102-6. doi: 10.1212/01.wnl.0000167607.63000.38.

  PMID: 16009893 BACKGROUND

• Fillenbaum GG, van Belle G, Morris JC, Mohs RC, Mirra SS, Davis PC, Tariot PN, Silverman JM, Clark CM, Welsh-Bohmer KA, Heyman A. Consortium to Establish a Registry for Alzheimer's Disease (CERAD): the first twenty years. Alzheimers Dement. 2008 Mar;4(2):96-109. doi: 10.1016/j.jalz.2007.08.005.

  PMID: 18631955 BACKGROUND

• Hallikainen I, Hanninen T, Fraunberg M, Hongisto K, Valimaki T, Hiltunen A, Karppi P, Sivenius J, Soininen H, Koivisto AM; ALSOVA study group. Progression of Alzheimer's disease during a three-year follow-up using the CERAD-NB total score: Kuopio ALSOVA study. Int Psychogeriatr. 2013 Aug;25(8):1335-44. doi: 10.1017/S1041610213000653. Epub 2013 May 16.

  PMID: 23676340 BACKGROUND

• Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.

  PMID: 6496779 BACKGROUND

• Morris JC, Mohs RC, Rogers H, Fillenbaum G, Heyman A. Consortium to establish a registry for Alzheimer's disease (CERAD) clinical and neuropsychological assessment of Alzheimer's disease. Psychopharmacol Bull. 1988;24(4):641-52. No abstract available.

  PMID: 3249766 BACKGROUND

• Ehrensperger MM, Berres M, Taylor KI, Monsch AU. Early detection of Alzheimer's disease with a total score of the German CERAD. J Int Neuropsychol Soc. 2010 Sep;16(5):910-20. doi: 10.1017/S1355617710000822. Epub 2010 Aug 4.

  PMID: 20682088 BACKGROUND

• Rossetti HC, Munro Cullum C, Hynan LS, Lacritz LH. The CERAD Neuropsychologic Battery Total Score and the progression of Alzheimer disease. Alzheimer Dis Assoc Disord. 2010 Apr-Jun;24(2):138-42. doi: 10.1097/WAD.0b013e3181b76415.

  PMID: 20505431 BACKGROUND

• Seo EH, Lee DY, Lee JH, Choo IH, Kim JW, Kim SG, Park SY, Shin JH, Do YJ, Yoon JC, Jhoo JH, Kim KW, Woo JI. Total scores of the CERAD neuropsychological assessment battery: validation for mild cognitive impairment and dementia patients with diverse etiologies. Am J Geriatr Psychiatry. 2010 Sep;18(9):801-9. doi: 10.1097/JGP.0b013e3181cab764.

  PMID: 20220577 BACKGROUND

• Irizarry MC, Webb DJ, Bains C, Barrett SJ, Lai RY, Laroche JP, Hosford D, Maher-Edwards G, Weil JG. Predictors of placebo group decline in the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS-Cog) in 24 week clinical trials of Alzheimer's disease. J Alzheimers Dis. 2008 Jul;14(3):301-11. doi: 10.3233/jad-2008-14304.

  PMID: 18599956 BACKGROUND

• Robert P, Ferris S, Gauthier S, Ihl R, Winblad B, Tennigkeit F. Review of Alzheimer's disease scales: is there a need for a new multi-domain scale for therapy evaluation in medical practice? Alzheimers Res Ther. 2010 Aug 26;2(4):24. doi: 10.1186/alzrt48.

  PMID: 20796301 BACKGROUND

• Lehrner, J.; Maly, J.; Gleiß, A.; Auff, E. & Dal-Bianco, P., Demenzdiagnostik mit Hilfe der Vienna Neuropsychologischen Testbatterie (VNTB): Standardisierung, Normierung und Validierung, Psychol. Österreich, 4, 358-365, 2007.

  BACKGROUND

• Shulman, K. I.; Shedletsky, R. & Silver, I. L.The challenge of time: Clock-drawing and cognitive function in the elderly. International journal of geriatric psychiatry, Wiley Online Library 1: 135-140, 1986.

  BACKGROUND

• Kogler, B. Subjective Memory Complaint in Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease. Vienna: University of Vienna, 2013

  BACKGROUND

• Lehrner J, Moser D, Klug S, Gleiss A, Auff E, Dal-Bianco P, Pusswald G. Subjective memory complaints, depressive symptoms and cognition in patients attending a memory outpatient clinic. Int Psychogeriatr. 2014 Mar;26(3):463-73. doi: 10.1017/S1041610213002263. Epub 2013 Dec 5.

  PMID: 24308705 BACKGROUND

• Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist. 1969 Autumn;9(3):179-86. No abstract available.

  PMID: 5349366 BACKGROUND

• BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.

  PMID: 13688369 BACKGROUND

• Shah P, Gaule A, Sowden S, Bird G, Cook R. The 20-item prosopagnosia index (PI20): a self-report instrument for identifying developmental prosopagnosia. R Soc Open Sci. 2015 Jun 24;2(6):140343. doi: 10.1098/rsos.140343. eCollection 2015 Jun.

  PMID: 26543567 BACKGROUND

• Cummings JL. The Neuropsychiatric Inventory: assessing psychopathology in dementia patients. Neurology. 1997 May;48(5 Suppl 6):S10-6. doi: 10.1212/wnl.48.5_suppl_6.10s.

  PMID: 9153155 BACKGROUND

• Sperling RA, Bates JF, Cocchiarella AJ, Schacter DL, Rosen BR, Albert MS. Encoding novel face-name associations: a functional MRI study. Hum Brain Mapp. 2001 Nov;14(3):129-39. doi: 10.1002/hbm.1047.

  PMID: 11559958 BACKGROUND

• Matt E, Mitterwallner M, Radjenovic S, Grigoryeva D, Weber A, Stogmann E, Domitner A, Zettl A, Osou S, Beisteiner R. Ultrasound Neuromodulation With Transcranial Pulse Stimulation in Alzheimer Disease: A Randomized Clinical Trial. JAMA Netw Open. 2025 Feb 3;8(2):e2459170. doi: 10.1001/jamanetworkopen.2024.59170.

  PMID: 40009384 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

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: September 7, 2018
• First Posted: December 10, 2018
• Study Start: January 1, 2017
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

AU (1)