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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control.
This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control.
50 Patients will be randomly assigned to either the interleaving stimulation modes group (ISG) or the empirical stimulation modes group (ESG). In ISG, empirical stimulation for the first 3 months, followed by interleaving programming period for 6 months, and any stimulation decided by the neurologists/neurosurgeons for the final 3 months. In ESG, empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months. The change of dyskinesia scores (UPDRS IV, item 32 + item 33), Parkinson's disease quality of life-39 (PDQ-39) scores, scores of United Parkinson's Disease Rating Scale Part III as well as scores of neuropsychological Battery in interleaving stimulation compared to empirical programming modes will be measured based on corresponding time frame. Finally, the results will be analyzed via proper statistical methods and thus the conclusion will be drawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| empirical stimulation modes group (ESG) | Active Comparator | empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months. |
|
| interleaving stimulation modes group (ISG) | Experimental | empirical stimulation for the first 3 months, followed by interleaving programming period for 6 months, and any stimulation decided by the neurologists/neurosurgeons for the final 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interleaving stimulation | Device | ILS consists of two rapid and alternate stimulation programs with different contacts, amplitudes, and pulse width but the same frequency up to a maximum of 125Hz. Contact selection is determined by postoperative stereotactic computed tomography and clinical evaluation to achieve a balance between motor improvement and tolerable side effects. For example, ILS is successfully applied for PD motor symptoms (stimulation of subthalamic nucleus) as well as dyskinesia (additional stimulation of zona incerta). |
| Measure | Description | Time Frame |
|---|---|---|
| dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33) | Measure the changes of dyskinesia scores (United Parkinson's Disease Rating Scale Part IV, item 32 + item 33) in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 4 (poor health). | 3 months and 9 months |
| Parkinson's disease quality of life-39 (PDQ-39) scores | Measure the changes of Parkinson's disease quality of life-39 (PDQ-39) scores in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 156 (poor health). | 3 months and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| scores of United Parkinson's Disease Rating Scale Part III | Measure the changes of scores of United Parkinson's Disease Rating Scale Part III in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (good health) to 132 (poor health). | 3 months and 9 months |
| Montreal cognitive assessment scores |
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Inclusion Criteria:
1. Patients at the age of 30-65 years old. 2. Patients diagnosed as Parkinson's disease according to the UK Parkinson's Disease Society Brain Bank criteria.
3. Patients at Hoehn and Yahr stage 3 or lower in the on-state and stage 2 - 4 in the off-state.
4. The disease duration of 5 years or more. 5. Patients with deep levodopa-responsive Parkinson's disease, and are not adequately controlled by drug therapy.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian-Jun Wu, MD | Contact | 86-21-52888163 | jungliw@gmail.com | |
| Feng-Tao Liu, MD | Contact | 86-21-52888163 | liufengtao@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Feng-Tao Liu, MD | Huashan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10715510 | Background | Wiens BL, Iglewicz B. Design and analysis of three treatment equivalence trials. Control Clin Trials. 2000 Apr;21(2):127-37. doi: 10.1016/s0197-2456(99)00052-5. | |
| 23406026 | Background | Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Halbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltete D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Kruger R, Pinsker MO, Amtage F, Regis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158. |
| Label | URL |
|---|---|
| Devroye, Luc. 1986. Non-Uniform Random Variate Generation. Springer-Verlag. New York. | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2022 | Jan 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 20, 2022 | Jan 25, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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50 Patients will be randomly assigned to either the interleaving stimulation modes group (ISG) or the empirical stimulation modes group (ESG).
ISG: empirical stimulation for the first 3 months, followed by interleaving programming period for 6 months, and any stimulation decided by the neurologists/neurosurgeons for the final 3 months.
ESG: empirical programming for the first 9 months' period, followed by any stimulation decided by the neurologists/neurosurgeons for the final 3 months.
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Randomization is done by computer-generated pairwise according to order of enrolment, so that similar numbers of patients are recruited to each study group. The chief investigator generates the randomization sequence. The randomization scheme is kept in sealed envelopes. The randomization sequence was revealed only to the unmasked clinician responsible for the stimulation programming, but not to the rater. Patients were masked to randomisation group.
|
| empirical stimulation | Device | Patients are settled with simple polar stimulation with combined parameters adjustment (monopolar mode, 60~90µs pulse width, 130~185Hz frequency and varied voltage) during the follow-up. |
|
Measure the scores of Montreal cognitive assessment in interleaving stimulation compared to empirical programming modes. The total scores range from 0 (poor cognition) to 30 (good cognition). |
| 3 months and 9 months |
| 23168021 | Background | Odekerken VJ, van Laar T, Staal MJ, Mosch A, Hoffmann CF, Nijssen PC, Beute GN, van Vugt JP, Lenders MW, Contarino MF, Mink MS, Bour LJ, van den Munckhof P, Schmand BA, de Haan RJ, Schuurman PR, de Bie RM. Subthalamic nucleus versus globus pallidus bilateral deep brain stimulation for advanced Parkinson's disease (NSTAPS study): a randomised controlled trial. Lancet Neurol. 2013 Jan;12(1):37-44. doi: 10.1016/S1474-4422(12)70264-8. Epub 2012 Nov 16. |
| 31231293 | Background | Koeglsperger T, Palleis C, Hell F, Mehrkens JH, Botzel K. Deep Brain Stimulation Programming for Movement Disorders: Current Concepts and Evidence-Based Strategies. Front Neurol. 2019 May 21;10:410. doi: 10.3389/fneur.2019.00410. eCollection 2019. |
| 30654368 | Background | Kern DS, Picillo M, Thompson JA, Sammartino F, di Biase L, Munhoz RP, Fasano A. Interleaving Stimulation in Parkinson's Disease, Tremor, and Dystonia. Stereotact Funct Neurosurg. 2018;96(6):379-391. doi: 10.1159/000494983. Epub 2019 Jan 17. |
| 27930569 | Background | Zhang S, Zhou P, Jiang S, Wang W, Li P. Interleaving subthalamic nucleus deep brain stimulation to avoid side effects while achieving satisfactory motor benefits in Parkinson disease: A report of 12 cases. Medicine (Baltimore). 2016 Dec;95(49):e5575. doi: 10.1097/MD.0000000000005575. |
| 31295615 | Background | Franca C, Barbosa ER, Iglesio R, Teixeira MJ, Cury RG. Interleaving Stimulation in Parkinson Disease: Interesting to Whom? World Neurosurg. 2019 Oct;130:e786-e793. doi: 10.1016/j.wneu.2019.06.223. Epub 2019 Jul 8. |
| 29659494 | Background | Khabarova EA, Denisova NP, Dmitriev AB, Slavin KV, Verhagen Metman L. Deep Brain Stimulation of the Subthalamic Nucleus in Patients with Parkinson Disease with Prior Pallidotomy or Thalamotomy. Brain Sci. 2018 Apr 16;8(4):66. doi: 10.3390/brainsci8040066. |
| 31571277 | Background | Bouthour W, Bereau M, Kibleur A, Zacharia A, Tomkova Chaoui E, Fleury V, Benis D, Momjian S, Bally J, Luscher C, Krack P, Burkhard PR. Dyskinesia-inducing lead contacts optimize outcome of subthalamic stimulation in Parkinson's disease. Mov Disord. 2019 Nov;34(11):1728-1734. doi: 10.1002/mds.27853. Epub 2019 Sep 30. |
| 26968806 | Background | Picillo M, Lozano AM, Kou N, Puppi Munhoz R, Fasano A. Programming Deep Brain Stimulation for Parkinson's Disease: The Toronto Western Hospital Algorithms. Brain Stimul. 2016 May-Jun;9(3):425-437. doi: 10.1016/j.brs.2016.02.004. Epub 2016 Feb 12. |
| 31483534 | Background | Aquino CC, Duffley G, Hedges DM, Vorwerk J, House PA, Ferraz HB, Rolston JD, Butson CR, Schrock LE. Interleaved deep brain stimulation for dyskinesia management in Parkinson's disease. Mov Disord. 2019 Nov;34(11):1722-1727. doi: 10.1002/mds.27839. Epub 2019 Sep 4. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |