An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

An Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in Poland

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02406105
• Other study ID #: FSRSPD-COI-03
• Status: Recruiting
• Phase: Phase 2
• First received: February 22, 2015
• Last updated: April 1, 2015
• Start date: January 2015
• Est. completion date: December 2020

Study information

• Verified date: March 2015
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: Leszek Miszczyk, MD, PhD
• Phone: 0048322788001
• Email: leszek[@]io.gliwice.pl
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Basic treatment patients with Parkinson's disease (PD - Parkinson's disease) or essential tremor (ET - essential tremor) is a pharmacotherapy. In the case of lack of its effectiveness, the gold standard procedure is deep brain stimulation (DBS). Despite the proven efficacy, still remains a group of patients not eligible for this treatment. in such cases, ablation within the deep structures of the brain (thalamotomy, subthalamotomy, pallidotomy) can be considered.

Thermoablation and radiosurgery (SRS - Stereotactic radiosurgery) are used: SRS is prefered for patients who are not candidates for invasive procedures.

27 patients will be enrolled in this study. All patients will be immobilized in thermoplastic masks and planned (RT) on the base of CT/MRI fusion.

The initial total dose in the target volume (thalamic nuclei complex - VoP and VoA ) will be 70 Gy given in one fraction. The dose will be escalated every 5 Gy and the treatment effect and possible side effects will be evaluated. Dose escalation will be finished at a dose at which the effect of treatment will be satisfactory, or if side effects are unacceptable. The highest dose tested dose will be 110 Gy. Three patients will be irradiated with particular doses and observed at least 3 moths; then study will be continued.

Patients will be controlled 3, 6, 9, 12, 18 months after treatment completion and, next every each 6 months. Neurologic and neuropsychologic status, local effect (MRI ) and eventual toxicity will be checked during follow-up (FU).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 2020
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Radiation:
• Radiosurgical thalamotomy
Cybernetic microradiosurgery based thalamotomy

Drug:
• CyberKnife

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch	Gliwice	Wybrzeze AK 15

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

References & Publications (19)

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. — View Citation

Duma CM. Movement disorder radiosurgery--planning, physics and complication avoidance. Prog Neurol Surg. 2007;20:249-66. — View Citation

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. — View Citation

Friehs GM, Park MC, Goldman MA, Zerris VA, Norén G, Sampath P. Stereotactic radiosurgery for functional disorders. Neurosurg Focus. 2007;23(6):E3. Review. — View Citation

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. Review. — View Citation

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. Erratum in: J Neurosurg. 2008 Mar;108(3):635. — View Citation

LEKSELL L. The stereotaxic method and radiosurgery of the brain. Acta Chir Scand. 1951 Dec 13;102(4):316-9. — View Citation

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. — View Citation

Lindquist C, Kihlström L, Hellstrand E. Functional neurosurgery--a future for the gamma knife? Stereotact Funct Neurosurg. 1991;57(1-2):72-81. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stancanello J, Romanelli P, Pantelis E, Sebastiano F, Modugno N. Atlas-based functional radiosurgery: early results. Med Phys. 2009 Feb;36(2):457-63. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Safety of treatment (evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema)	Safety of treatment will be evaluated using RTOG/EORTC Acute Radiation Morbidity Scoring Criteria and Late Radiation Morbidity Scoring Schema	1 year	Yes
Secondary	Evaluation of the value of magnetic resonance spectroscopy as a tool for metabolites proportions changes after PD radiosurgery (spectra of metabolites in irradiated volume)	None grading system of serial spectroscopy dedicated for such purpose exists. We will check spectra of metabolites in irradiated volume and proportions between them, trying to form conclusions considering necrosis/gliosis forming.	2 years	Yes
Secondary	Implementation of CyberKnife radiosurgery for Parkinson disease patients not eligible for other treatment modality		2 years	Yes