Deep brain stimulation in early Parkinson's disease

Enrollment experience from a pilot trial

P. D. Charles, R. M. Dolhun, C. E. Gill, T. L. Davis, M. J. Bliton, M. G. Tramontana, R. M. Salomon, Lily Wang, P. Hedera, F. T. Phibbs, J. S. Neimat, P. E. Konrad

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background: Deep brain stimulation (DBS) of the subthalamic nucleus is an accepted therapy for advanced Parkinson's disease (PD). In animal models, pharmacologic ablation and stimulation of the subthalamic nucleus have resulted in clinical improvement and, in some cases, improved survival of dopaminergic neurons. DBS has not been studied in the early stages of PD, but early application should be explored to evaluate safety, efficacy, and the potential to alter disease progression. Methods: We are conducting a prospective, randomized, single-blind clinical trial of optimal drug therapy (ODT) compared to medication plus DBS (ODT + DBS) in subjects with Hoehn & Yahr Stage II idiopathic PD who are without motor fluctuations or dementia. We report here subject screening, enrollment, baseline characteristics, and adverse events. Results: 30 subjects (average age 60 ± 6.9 years, average duration of medicine 2.1 ± 1.3 years, average UPDRS-III scores 14.9 on medication and 27.0 off medication) are enrolled in the ongoing study. Twelve of 15 subjects randomized to DBS experienced perioperative adverse events, the majority of which were related to the procedure or device and resolved without sequelae. Frequently reported adverse events included wound healing problems, headache, edema, and confusion. Conclusion: This report demonstrates that subjects with early stage PD can be successfully recruited, consented and retained in a long-term clinical trial of DBS. Our ongoing pilot investigation will provide important preliminary safety and tolerability data concerning the application of DBS in early stage PD.

Original languageEnglish (US)
Pages (from-to)268-273
Number of pages6
JournalParkinsonism and Related Disorders
Volume18
Issue number3
DOIs
StatePublished - Mar 1 2012
Externally publishedYes

Fingerprint

Deep Brain Stimulation
Parkinson Disease
Subthalamic Nucleus
Clinical Trials
Safety
Drug Therapy
Confusion
Dopaminergic Neurons
Wound Healing
Headache
Dementia
Disease Progression
Edema
Animal Models
Medicine
Equipment and Supplies

Keywords

  • Deep brain stimulation
  • Parkinson's disease
  • Subthalamic nucleus

ASJC Scopus subject areas

  • Geriatrics and Gerontology
  • Clinical Neurology
  • Neurology

Cite this

Charles, P. D., Dolhun, R. M., Gill, C. E., Davis, T. L., Bliton, M. J., Tramontana, M. G., ... Konrad, P. E. (2012). Deep brain stimulation in early Parkinson's disease: Enrollment experience from a pilot trial. Parkinsonism and Related Disorders, 18(3), 268-273. https://doi.org/10.1016/j.parkreldis.2011.11.001

Deep brain stimulation in early Parkinson's disease : Enrollment experience from a pilot trial. / Charles, P. D.; Dolhun, R. M.; Gill, C. E.; Davis, T. L.; Bliton, M. J.; Tramontana, M. G.; Salomon, R. M.; Wang, Lily; Hedera, P.; Phibbs, F. T.; Neimat, J. S.; Konrad, P. E.

In: Parkinsonism and Related Disorders, Vol. 18, No. 3, 01.03.2012, p. 268-273.

Research output: Contribution to journalArticle

Charles, PD, Dolhun, RM, Gill, CE, Davis, TL, Bliton, MJ, Tramontana, MG, Salomon, RM, Wang, L, Hedera, P, Phibbs, FT, Neimat, JS & Konrad, PE 2012, 'Deep brain stimulation in early Parkinson's disease: Enrollment experience from a pilot trial', Parkinsonism and Related Disorders, vol. 18, no. 3, pp. 268-273. https://doi.org/10.1016/j.parkreldis.2011.11.001
Charles, P. D. ; Dolhun, R. M. ; Gill, C. E. ; Davis, T. L. ; Bliton, M. J. ; Tramontana, M. G. ; Salomon, R. M. ; Wang, Lily ; Hedera, P. ; Phibbs, F. T. ; Neimat, J. S. ; Konrad, P. E. / Deep brain stimulation in early Parkinson's disease : Enrollment experience from a pilot trial. In: Parkinsonism and Related Disorders. 2012 ; Vol. 18, No. 3. pp. 268-273.
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AU - Bliton, M. J.

AU - Tramontana, M. G.

AU - Salomon, R. M.

AU - Wang, Lily

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AU - Neimat, J. S.

AU - Konrad, P. E.

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