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Prospective randomized double-blind controlled trial for deep brain stimulation of the thalamus and the posterior subthalamic nucleus in the treatment of essential tremor

Differential study of PSA target and VIM target DBS surgery for idiopathic tremor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024555
Enrollment
Unknown
Registered
2019-07-16
Start date
2019-07-09
Completion date
Unknown
Last updated
2019-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential tremor

Interventions

Group 1 versus Group 2:PSA/VIM Deep brain stimulation

Sponsors

Department of Functional Neurosurgery, RuiJin Hospital, affiliated with Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old at the time of enrollment; 2. Based on MDS 2017 consensus diagnosis for primary tremor; 3. Duration of ET symptoms: >=3 years of motor symptoms; 4. If the patient takes a tremor medication, the tremor drug is stable 28 days prior to informed consent; 5. Written informed consent was signed prior to entering the study.

Exclusion criteria

Exclusion criteria: 1. Mental illnesses that may affect the subject's ability to comply with the research protocol requirements (eg, biphasic, schizophrenia, mood disorders with psychotic characteristics, group B personality disorder); 2. Severe cognitive impairment, MOCA <24; 3. Any drug or alcohol abuse currently under the DSM-V standard; 4. Any intracranial abnormalities that impede DBS surgery; any history of recurrent or unprovoked seizures; any previous treatment for dyskinesia involves intracranial surgery or instrument implantation; any history of hemorrhagic stroke; there may be any interference with the study procedure or may confuse the study endpoint Major disease assessed; 5. Life expectancy for any lifetime, <1 year.

Design outcomes

Primary

MeasureTime frame
TRS;frequency of EMG;

Secondary

MeasureTime frame
VDI;Base frequency perturbation;Amplitude perturbation;Irregularity;Overall severity;DSI;MSDA test;International Cooperative Ataxia Rating Scale;Walking speed;Step size;Time per step;Step width;Dual support time;Percentage of missed steps;

Countries

China

Contacts

Public ContactDianyou Li

Department of Functional Neurosurgery, RuiJin Hospital, affiliated with Shanghai Jiaotong University School of Medicine

ldy11483@rjh.com.cn+86 21 64370045-632001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026