Multitarget Stereotactic Electrophysiological Recording and Stimulation for Tourette Syndrome
NCT ID: NCT06889480
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
5 participants
INTERVENTIONAL
2024-10-01
2026-03-31
Brief Summary
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In this study, researchers will use stereoelectroencephalography (SEEG) and electrocorticography (ECoG) to record brain activity in key areas involved in movement and emotion, including the nucleus accumbens (NAc), anterior limb of the internal capsule (ALIC), insular cortex, anterior cingulate cortex (ACC), central medial thalamic nucleus (CM), globus pallidus internus (GPi), and motor cortex (M1). They will test stimulation in these areas to evaluate acute therapeutic effect for each target and to identify a new effective new target.
Later, participants will receive DBS treatment under three different conditions, each for 1 month to identify the optimal target:
1. Stimulation at the new target,
2. Stimulation at the CM,
3. Sham stimulation (does not actually stimulate).
Finally, DBS will be continued at the optimal target for an additional three months to confirm its therapeutic impact.
By analyzing the brain activity and comparing these conditions, the study will clarify the neural mechanisms underlying TS and learn which target works best to lower tics and improve overall quality of life for TS patients.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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New Target DBS
Participants in this arm will receive active deep brain stimulation targeted to a novel brain region. The new target is identified through electrophysiological brain mapping and 24-hour stimulation. Stimulation parameters (frequency, voltage, pulse width) will be individually optimized based on mapping results.
New Target DBS
Participants in this arm will receive active DBS targeting a novel brain region identified via electrophysiological brain mapping. A DBS electrode will be implanted at the new target, and stimulation parameters (including frequency, voltage, and pulse width) are individually optimized based on mapping and 24-hour testing. The procedure is performed using a robotic system for precise electrode placement, and the device is provided by Beijing PINS Medical Co., Ltd.
CM-DBS
Participants in this arm will receive active deep brain stimulation at the central medial thalamic nucleus (CM), a well-established target for TS treatment. Stimulation settings are determined during electrophysiological brain mapping and 24-hour stimulation. This arm serves as the active comparator, enabling the evaluation of relative efficacy and safety between the conventional CM target and the new target intervention.
CM-DBS
This intervention involves active DBS at the central medial thalamic nucleus (CM) -a widely used target in TS treatment. A DBS electrode is implanted at the CM target, with stimulation settings determined through electrophysiological brain mapping and subsequent 24-hour stimulation. This arm serves as an active comparator, with stimulation administered during a 1-month period in the crossover phase. The same device and robotic-assisted implantation are used to ensure consistency and precision.
Sham Stimulation
Participants in this arm will undergo identical surgical procedures and follow-up assessments as in the active stimulation arms but will receive sham (inactive) stimulation. This arm is designed to control for placebo effects and ensure that any observed improvements in TS symptoms are attributable to the active interventions.
Sham Stimulation
Participants assigned to the sham stimulation arm undergo the identical surgical procedure and electrode implantation as those in the active arms. However, during the stimulation periods, the device is programmed to deliver no active stimulation. This sham intervention is designed to control for placebo effects and ensure that any observed improvements in TS symptoms are attributable to the active DBS interventions.
Interventions
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New Target DBS
Participants in this arm will receive active DBS targeting a novel brain region identified via electrophysiological brain mapping. A DBS electrode will be implanted at the new target, and stimulation parameters (including frequency, voltage, and pulse width) are individually optimized based on mapping and 24-hour testing. The procedure is performed using a robotic system for precise electrode placement, and the device is provided by Beijing PINS Medical Co., Ltd.
CM-DBS
This intervention involves active DBS at the central medial thalamic nucleus (CM) -a widely used target in TS treatment. A DBS electrode is implanted at the CM target, with stimulation settings determined through electrophysiological brain mapping and subsequent 24-hour stimulation. This arm serves as an active comparator, with stimulation administered during a 1-month period in the crossover phase. The same device and robotic-assisted implantation are used to ensure consistency and precision.
Sham Stimulation
Participants assigned to the sham stimulation arm undergo the identical surgical procedure and electrode implantation as those in the active arms. However, during the stimulation periods, the device is programmed to deliver no active stimulation. This sham intervention is designed to control for placebo effects and ensure that any observed improvements in TS symptoms are attributable to the active DBS interventions.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Tourette Syndrome according to DSM-V criteria, defined as:
i. The presence of multiple motor tics and at least one vocal tic at some point (not necessarily simultaneous).
ii. Tics that have persisted for more than 1 year from their onset.
iii. Onset of tics occurring before the age of 18.
iv. The disorder is not attributable to the physiological effects of a substance or another medical condition.
3. A Yale Global Tic Severity Scale (YGTSS) total score greater than 35 (on a scale of 0-50) for at least 1 year, with a motor tic score of ≥15, and tics being the primary cause of disability.
4. Inadequate response to conservative treatments (standard pharmacological and behavioral therapy).
5. Disease duration of more than 1 year.
6. Any coexisting medical, neurological, or psychiatric disorders have been treated and remain stable for at least 6 months.
7. A stable psychosocial environment.
8. Neuropsychological evaluation demonstrating that the candidate can tolerate the surgical procedure, postoperative follow-up, and potential adverse events.
9. The participant, or his/her legal representative, is able to provide written informed consent.
Exclusion Criteria
2. History of drug or alcohol dependence within the past 6 months.
3. Abnormal brain structure as indicated by CT or MRI scans.
4. Presence of any condition that could lead to surgical failure or interfere with postoperative management.
5. Diagnosis of factitious disorder, malingering, or psychogenic tics.
6. Contraindications to neurosurgical procedures (e.g., history of cerebral infarction, hydrocephalus, cerebral atrophy, or post-stroke sequelae).
7. Contraindications for CT/MRI scanning (e.g., claustrophobia).
8. Pregnancy or lactation, or a positive pregnancy test prior to randomization.
9. Contraindications to general anesthesia (e.g., severe arrhythmia, severe anemia, hepatic or renal dysfunction).
10. Expected survival of less than 12 months.
11. Participation in other interventional clinical studies that may influence outcome assessments.
12. Any other condition that, in the investigator's judgment, renders the candidate unsuitable for participation or poses a significant risk (e.g., inability to understand study procedures or poor adherence).
18 Years
60 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Jianguo Zhang
Director of Department of Functional Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Principal Investigators
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Jianguo Zhang, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Martinez-Ramirez D, Jimenez-Shahed J, Leckman JF, Porta M, Servello D, Meng FG, Kuhn J, Huys D, Baldermann JC, Foltynie T, Hariz MI, Joyce EM, Zrinzo L, Kefalopoulou Z, Silburn P, Coyne T, Mogilner AY, Pourfar MH, Khandhar SM, Auyeung M, Ostrem JL, Visser-Vandewalle V, Welter ML, Mallet L, Karachi C, Houeto JL, Klassen BT, Ackermans L, Kaido T, Temel Y, Gross RE, Walker HC, Lozano AM, Walter BL, Mari Z, Anderson WS, Changizi BK, Moro E, Zauber SE, Schrock LE, Zhang JG, Hu W, Rizer K, Monari EH, Foote KD, Malaty IA, Deeb W, Gunduz A, Okun MS. Efficacy and Safety of Deep Brain Stimulation in Tourette Syndrome: The International Tourette Syndrome Deep Brain Stimulation Public Database and Registry. JAMA Neurol. 2018 Mar 1;75(3):353-359. doi: 10.1001/jamaneurol.2017.4317.
Muller-Vahl KR, Szejko N, Saryyeva A, Schrader C, Krueger D, Horn A, Kuhn AA, Krauss JK. Randomized double-blind sham-controlled trial of thalamic versus GPi stimulation in patients with severe medically refractory Gilles de la Tourette syndrome. Brain Stimul. 2021 May-Jun;14(3):662-675. doi: 10.1016/j.brs.2021.04.004. Epub 2021 Apr 18.
Schuller T, Gruendler TOJ, Smith EE, Baldermann JC, Kohl S, Fischer AG, Visser-Vandewalle V, Ullsperger M, Kuhn J, Huys D. Performance monitoring in obsessive-compulsive disorder: Insights from internal capsule/nucleus accumbens deep brain stimulation. Neuroimage Clin. 2021;31:102746. doi: 10.1016/j.nicl.2021.102746. Epub 2021 Jun 29.
Xiong B, Li B, Wen R, Gao Y, Gong F, Li D, Xu Y, Deng H, Xiao L, Yin S, Zhang W, Lozano AM, Wang W. Use of differential stimulation of the nucleus accumbens and anterior limb of the internal capsule to improve outcomes of obsessive-compulsive disorder. J Neurosurg. 2023 May 26;139(5):1376-1385. doi: 10.3171/2023.4.JNS221824. Print 2023 Nov 1.
McGovern RA, Sheth SA. Role of the dorsal anterior cingulate cortex in obsessive-compulsive disorder: converging evidence from cognitive neuroscience and psychiatric neurosurgery. J Neurosurg. 2017 Jan;126(1):132-147. doi: 10.3171/2016.1.JNS15601. Epub 2016 Apr 1.
O'Neill J, Piacentini JC, Peterson BS. Cingulate role in Tourette syndrome. Handb Clin Neurol. 2019;166:165-221. doi: 10.1016/B978-0-444-64196-0.00011-X.
Jackson SR, Sigurdsson HP, Dyke K, Condon M, Jackson GM. The role of the cingulate cortex in the generation of motor tics and the experience of the premonitory urge-to-tic in Tourette syndrome. J Neuropsychol. 2021 Sep;15(3):340-362. doi: 10.1111/jnp.12242. Epub 2021 Mar 27.
Jackson SR, Loayza J, Crighton M, Sigurdsson HP, Dyke K, Jackson GM. The role of the insula in the generation of motor tics and the experience of the premonitory urge-to-tic in Tourette syndrome. Cortex. 2020 May;126:119-133. doi: 10.1016/j.cortex.2019.12.021. Epub 2020 Jan 22.
Neumann WJ, Huebl J, Brucke C, Lofredi R, Horn A, Saryyeva A, Muller-Vahl K, Krauss JK, Kuhn AA. Pallidal and thalamic neural oscillatory patterns in tourette's syndrome. Ann Neurol. 2018 Oct;84(4):505-514. doi: 10.1002/ana.25311. Epub 2018 Oct 4.
Gunduz A, Okun MS. A Review and Update on Tourette Syndrome: Where Is the Field Headed? Curr Neurol Neurosci Rep. 2016 Apr;16(4):37. doi: 10.1007/s11910-016-0633-x.
Cagle JN, Okun MS, Opri E, Cernera S, Molina R, Foote KD, Gunduz A. Differentiating tic electrophysiology from voluntary movement in the human thalamocortical circuit. J Neurol Neurosurg Psychiatry. 2020 May;91(5):533-539. doi: 10.1136/jnnp-2019-321973. Epub 2020 Mar 5.
Bohlhalter S, Goldfine A, Matteson S, Garraux G, Hanakawa T, Kansaku K, Wurzman R, Hallett M. Neural correlates of tic generation in Tourette syndrome: an event-related functional MRI study. Brain. 2006 Aug;129(Pt 8):2029-37. doi: 10.1093/brain/awl050. Epub 2006 Mar 6.
Wang Z, Maia TV, Marsh R, Colibazzi T, Gerber A, Peterson BS. The neural circuits that generate tics in Tourette's syndrome. Am J Psychiatry. 2011 Dec;168(12):1326-37. doi: 10.1176/appi.ajp.2011.09111692. Epub 2011 Sep 28.
Johnson KA, Duffley G, Foltynie T, Hariz M, Zrinzo L, Joyce EM, Akram H, Servello D, Galbiati TF, Bona A, Porta M, Meng FG, Leentjens AFG, Gunduz A, Hu W, Foote KD, Okun MS, Butson CR. Basal Ganglia Pathways Associated With Therapeutic Pallidal Deep Brain Stimulation for Tourette Syndrome. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Oct;6(10):961-972. doi: 10.1016/j.bpsc.2020.11.005. Epub 2020 Nov 24.
Johnson KA, Fletcher PT, Servello D, Bona A, Porta M, Ostrem JL, Bardinet E, Welter ML, Lozano AM, Baldermann JC, Kuhn J, Huys D, Foltynie T, Hariz M, Joyce EM, Zrinzo L, Kefalopoulou Z, Zhang JG, Meng FG, Zhang C, Ling Z, Xu X, Yu X, Smeets AY, Ackermans L, Visser-Vandewalle V, Mogilner AY, Pourfar MH, Almeida L, Gunduz A, Hu W, Foote KD, Okun MS, Butson CR. Image-based analysis and long-term clinical outcomes of deep brain stimulation for Tourette syndrome: a multisite study. J Neurol Neurosurg Psychiatry. 2019 Oct;90(10):1078-1090. doi: 10.1136/jnnp-2019-320379. Epub 2019 May 25.
Frey J, Malaty IA. Tourette Syndrome Treatment Updates: a Review and Discussion of the Current and Upcoming Literature. Curr Neurol Neurosci Rep. 2022 Feb;22(2):123-142. doi: 10.1007/s11910-022-01177-8. Epub 2022 Feb 2.
Gao Y, Wang S, Wang A, Fan S, Ge Y, Wang H, Gao D, Wang J, Mao Z, Zhao H, Zhang H, Shi L, Liu H, Zhu G, Yang A, Bai Y, Zhang X, Liu C, Wang Q, Li R, Liang K, Brown KG, Cui Z, Han C, Zhang J, Meng F. Comparison of children and adults in deep brain stimulation for Tourette Syndrome: a large-scale multicenter study of 102 cases with long-term follow-up. BMC Med. 2024 May 30;22(1):218. doi: 10.1186/s12916-024-03432-w.
Schrock LE, Mink JW, Woods DW, Porta M, Servello D, Visser-Vandewalle V, Silburn PA, Foltynie T, Walker HC, Shahed-Jimenez J, Savica R, Klassen BT, Machado AG, Foote KD, Zhang JG, Hu W, Ackermans L, Temel Y, Mari Z, Changizi BK, Lozano A, Auyeung M, Kaido T, Agid Y, Welter ML, Khandhar SM, Mogilner AY, Pourfar MH, Walter BL, Juncos JL, Gross RE, Kuhn J, Leckman JF, Neimat JA, Okun MS; Tourette Syndrome Association International Deep Brain Stimulation (DBS) Database and Registry Study Group. Tourette syndrome deep brain stimulation: a review and updated recommendations. Mov Disord. 2015 Apr;30(4):448-71. doi: 10.1002/mds.26094. Epub 2014 Dec 5.
Baldermann JC, Schuller T, Huys D, Becker I, Timmermann L, Jessen F, Visser-Vandewalle V, Kuhn J. Deep Brain Stimulation for Tourette-Syndrome: A Systematic Review and Meta-Analysis. Brain Stimul. 2016 Mar-Apr;9(2):296-304. doi: 10.1016/j.brs.2015.11.005. Epub 2015 Dec 29.
Jafari F, Abbasi P, Rahmati M, Hodhodi T, Kazeminia M. Systematic Review and Meta-Analysis of Tourette Syndrome Prevalence; 1986 to 2022. Pediatr Neurol. 2022 Dec;137:6-16. doi: 10.1016/j.pediatrneurol.2022.08.010. Epub 2022 Sep 5.
Liu ZS, Cui YH, Sun D, Lu Q, Jiang YW, Jiang L, Wang JQ, Luo R, Fang F, Zhou SZ, Wang Y, Cai FC, Lin Q, Xiong L, Zheng Y, Qin J. Current Status, Diagnosis, and Treatment Recommendation for Tic Disorders in China. Front Psychiatry. 2020 Aug 13;11:774. doi: 10.3389/fpsyt.2020.00774. eCollection 2020.
Hirschtritt ME, Lee PC, Pauls DL, Dion Y, Grados MA, Illmann C, King RA, Sandor P, McMahon WM, Lyon GJ, Cath DC, Kurlan R, Robertson MM, Osiecki L, Scharf JM, Mathews CA; Tourette Syndrome Association International Consortium for Genetics. Lifetime prevalence, age of risk, and genetic relationships of comorbid psychiatric disorders in Tourette syndrome. JAMA Psychiatry. 2015 Apr;72(4):325-33. doi: 10.1001/jamapsychiatry.2014.2650.
Johnson KA, Worbe Y, Foote KD, Butson CR, Gunduz A, Okun MS. Tourette syndrome: clinical features, pathophysiology, and treatment. Lancet Neurol. 2023 Feb;22(2):147-158. doi: 10.1016/S1474-4422(22)00303-9. Epub 2022 Oct 28.
Other Identifiers
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HX-B-2024057
Identifier Type: -
Identifier Source: org_study_id
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