NCT02406105

Brief Summary

Clinical objective of the study is estimation of effectiveness and safety of Cyber Knife based functional radiosurgery for Parkinson disease patients suffering from tremor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for phase_2 parkinson-disease

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

April 2, 2015

Status Verified

March 1, 2015

Enrollment Period

3.4 years

First QC Date

February 22, 2015

Last Update Submit

April 1, 2015

Conditions

Parkinson Disease

Keywords

tremorParkinson diseasefunctional radioablationCyber Knife radiosurgery

Outcome Measures

Primary Outcomes (1)

  • Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale

    Tremor reduction will be evaluated using Unified Parkinson's Disease Rating Scale (UDPRS)

    1 year

Secondary Outcomes (3)

  • Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)

    1 year

  • Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)

    2 years

  • Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality

    2 years

Study Arms (1)

Radiosurgical thalamotomy

EXPERIMENTAL

Cyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy

Radiation: Radiosurgical thalamotomyDrug: CyberKnife

Interventions

Radiosurgical thalamotomyRADIATION

Cybernetic microradiosurgery based thalamotomy

Radiosurgical thalamotomy
CyberKnifeDRUG
Radiosurgical thalamotomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopatic Parkinson Disease (PD)
  • Lack of effective pharmacotherapy
  • Lack of possibilities of qualifications to DBS (deep brain stimulation) procedure
  • Informed consent for participation in the study and for radiotherapy

You may not qualify if:

  • Age under 18
  • Pregnancy
  • Other than PD induced tremor
  • Dementia, psychosis.
  • Poor performance status
  • Atrophic cerebral changes, structural changes in basal nuclei
  • Lack of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch

Gliwice, Wybrzeze AK 15, 44-100, Poland

RECRUITING

Related Publications (19)

  • Hooper AK, Okun MS, Foote KD, Fernandez HH, Jacobson C, Zeilman P, Romrell J, Rodriguez RL. Clinical cases where lesion therapy was chosen over deep brain stimulation. Stereotact Funct Neurosurg. 2008;86(3):147-52. doi: 10.1159/000120426. Epub 2008 Mar 12.

    PMID: 18334856BACKGROUND

  • Niranjan A, Jawahar A, Kondziolka D, Lunsford LD. A comparison of surgical approaches for the management of tremor: radiofrequency thalamotomy, gamma knife thalamotomy and thalamic stimulation. Stereotact Funct Neurosurg. 1999;72(2-4):178-84. doi: 10.1159/000029723.

    PMID: 10853075BACKGROUND

  • Young RF, Shumway-Cook A, Vermeulen SS, Grimm P, Blasko J, Posewitz A, Burkhart WA, Goiney RC. Gamma knife radiosurgery as a lesioning technique in movement disorder surgery. J Neurosurg. 1998 Aug;89(2):183-93. doi: 10.3171/jns.1998.89.2.0183.

    PMID: 9688111BACKGROUND

  • Stancanello J, Romanelli P, Pantelis E, Sebastiano F, Modugno N. Atlas-based functional radiosurgery: early results. Med Phys. 2009 Feb;36(2):457-63. doi: 10.1118/1.3056460.

    PMID: 19291984BACKGROUND

  • LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. No abstract available.

    PMID: 14914373BACKGROUND

  • Lindquist C, Kihlstrom L, Hellstrand E. Functional neurosurgery--a future for the gamma knife? Stereotact Funct Neurosurg. 1991;57(1-2):72-81. doi: 10.1159/000099557.

    PMID: 1725560BACKGROUND

  • Young RF, Vermeulen S, Posewitz A, Shumway-Cook A. Pallidotomy with the gamma knife: a positive experience. Stereotact Funct Neurosurg. 1998 Oct;70 Suppl 1:218-28. doi: 10.1159/000056425.

    PMID: 9782254BACKGROUND

  • Duma CM, Jacques DB, Kopyov OV, Mark RJ, Copcutt B, Farokhi HK. Gamma knife radiosurgery for thalamotomy in parkinsonian tremor: a five-year experience. J Neurosurg. 1998 Jun;88(6):1044-9. doi: 10.3171/jns.1998.88.6.1044.

    PMID: 9609299BACKGROUND

  • Young RF, Jacques S, Mark R, Kopyov O, Copcutt B, Posewitz A, Li F. Gamma knife thalamotomy for treatment of tremor: long-term results. J Neurosurg. 2000 Dec;93 Suppl 3:128-35. doi: 10.3171/jns.2000.93.supplement.

    PMID: 11143229BACKGROUND

  • Niranjan A, Kondziolka D, Baser S, Heyman R, Lunsford LD. Functional outcomes after gamma knife thalamotomy for essential tremor and MS-related tremor. Neurology. 2000 Aug 8;55(3):443-6. doi: 10.1212/wnl.55.3.443.

    PMID: 10932286BACKGROUND

  • Okun MS, Stover NP, Subramanian T, Gearing M, Wainer BH, Holder CA, Watts RL, Juncos JL, Freeman A, Evatt ML, Schuele SU, Vitek JL, DeLong MR. Complications of gamma knife surgery for Parkinson disease. Arch Neurol. 2001 Dec;58(12):1995-2002. doi: 10.1001/archneur.58.12.1995.

    PMID: 11735773BACKGROUND

  • Friehs GM, Park MC, Goldman MA, Zerris VA, Noren G, Sampath P. Stereotactic radiosurgery for functional disorders. Neurosurg Focus. 2007;23(6):E3. doi: 10.3171/FOC-07/12/E3.

    PMID: 18081480BACKGROUND

  • Duma CM. Movement disorder radiosurgery--planning, physics and complication avoidance. Prog Neurol Surg. 2007;20:249-266. doi: 10.1159/000100168.

    PMID: 17317994BACKGROUND

  • Kondziolka D, Ong JG, Lee JY, Moore RY, Flickinger JC, Lunsford LD. Gamma Knife thalamotomy for essential tremor. J Neurosurg. 2008 Jan;108(1):111-7. doi: 10.3171/JNS/2008/108/01/0111.

    PMID: 18173319BACKGROUND

  • Young RF, Li F, Vermeulen S, Meier R. Gamma Knife thalamotomy for treatment of essential tremor: long-term results. J Neurosurg. 2010 Jun;112(6):1311-7. doi: 10.3171/2009.10.JNS09332.

    PMID: 19895197BACKGROUND

  • Ohye C, Higuchi Y, Shibazaki T, Hashimoto T, Koyama T, Hirai T, Matsuda S, Serizawa T, Hori T, Hayashi M, Ochiai T, Samura H, Yamashiro K. Gamma knife thalamotomy for Parkinson disease and essential tremor: a prospective multicenter study. Neurosurgery. 2012 Mar;70(3):526-35; discussion 535-6. doi: 10.1227/NEU.0b013e3182350893.

    PMID: 21904267BACKGROUND

  • Lim SY, Hodaie M, Fallis M, Poon YY, Mazzella F, Moro E. Gamma knife thalamotomy for disabling tremor: a blinded evaluation. Arch Neurol. 2010 May;67(5):584-8. doi: 10.1001/archneurol.2010.69.

    PMID: 20457958BACKGROUND

  • Franzini A, Marchetti M, Brait L, Milanesi I, Messina G, Forapani E, Broggi G, Fariselli L. Deep brain stimulation and frameless stereotactic radiosurgery in the treatment of bilateral parkinsonian tremor: target selection and case report of two patients. Acta Neurochir (Wien). 2011 May;153(5):1069-75. doi: 10.1007/s00701-011-0962-0. Epub 2011 Feb 20.

    PMID: 21336920BACKGROUND

  • Yu C, Main W, Taylor D, Kuduvalli G, Apuzzo ML, Adler JR Jr. An anthropomorphic phantom study of the accuracy of Cyberknife spinal radiosurgery. Neurosurgery. 2004 Nov;55(5):1138-49. doi: 10.1227/01.neu.0000141080.54647.11.

    PMID: 15509320BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseTremor

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Leszek Miszczyk, MD, PhD

    Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, Gliwice, Poland

    STUDY DIRECTOR

Central Study Contacts

Leszek Miszczyk, MD, PhD

CONTACT

0048322788001leszek@io.gliwice.pl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2015

First Posted

April 2, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2018

Study Completion

December 1, 2020

Last Updated

April 2, 2015

Record last verified: 2015-03

Locations

PL(1)