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Parkinson DiseasePhase 2NCT02406105

An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson Disease

A Phase 2 study testing Radiosurgical thalamotomy and CyberKnife in people with Parkinson Disease, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
Radiosurgical thalamotomy and CyberKnife
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 sitePoland
Study dates
Jan 2015to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Leszek Miszczyk, MD, PhD contact

0048322788001

leszek@io.gliwice.pl

Poland1 site, 1 recruiting

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

    Gliwice, Wybrzeze AK 15, 44-100

    Leszek Miszczyk, MD. PhD, +48322788001, leszek@io.gliwice.pl

    Leszek Miszczyk, MD, PhD

    Recruiting

Other trials in Poland

About this study

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

Read the detailed 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).

Being tested
Radiosurgical thalamotomy, CyberKnife
Keywords
tremor, Parkinson disease, functional radioablation, Cyber Knife radiosurgery
Medical subject headings
Parkinson Disease, Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radiosurgical thalamotomyRadiation

    Cybernetic microradiosurgery based thalamotomy

  • CyberKnifeDrug

Study groups in NCT02406105
Study groupRoleWhat they receive
Radiosurgical thalamotomyExperimentalCyber Knife based functional radiosurgical thalamotomy, photons 6MV, single dose 70-110 Gy
Receives: Radiation: Radiosurgical thalamotomy; Drug: CyberKnife

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale

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

    Measured: 1 year

Secondary outcomes (3)

  1. 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

    Measured: 1 year

  2. 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.

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2018 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02406105
Sponsor's protocol ID
FSRSPD-COI-03
Status last verified
Mar 2015
First submitted
22 Feb 2015
Last updated
2 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18334856

  • 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.

    PubMed 10853075

  • 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.

    PubMed 9688111

  • 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.

    PubMed 19291984

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

    PubMed 14914373

  • 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.

    PubMed 1725560

  • 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.

    PubMed 9782254

  • 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.

    PubMed 9609299

  • 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.

    PubMed 11143229

  • 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.

    PubMed 10932286

  • 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.

    PubMed 11735773

  • 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.

    PubMed 18081480

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

    PubMed 17317994

  • 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.

    PubMed 18173319

  • 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.

    PubMed 19895197

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiosurgical thalamotomy and CyberKnife in people with Parkinson Disease, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leszek Miszczyk, MD, PhD (0048322788001, leszek@io.gliwice.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tremor reduction evaluated using Unified Parkinson's Disease Rating Scale (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406105, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.

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