| CTRI Number |
CTRI/2024/03/064785 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychiatric Changes after Deep Brain Stimulation in Parkinsons Disease |
|
Scientific Title of Study
|
A Case-Control Study of Psychiatric Changes after Deep Brain Stimulation of the Subthalamic Nucleus in Parkinsons Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaurya Garg |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Department of Psychiatry, All India Institute of Medical Science, New Delhi
Department of Psychiatry, All India Institute of Medical Science, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871905372 |
| Fax |
|
| Email |
shaurya0398@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Patil |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Department of Psychiatry, All India Institute of Medical Science, New Delhi
Department of Psychiatry, All India Institute of Medical Science, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968721083 |
| Fax |
|
| Email |
drvaibhavp317@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Patil |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science, New Delhi |
| Address |
Department of Psychiatry, All India Institute of Medical Science, New Delhi
Department of Psychiatry, All India Institute of Medical Science, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968721083 |
| Fax |
|
| Email |
drvaibhavp317@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, All India Institute of Medical Science, New Delhi |
|
|
Primary Sponsor
|
| Name |
Department of Psychiatry All India Institute of Medical Science New Delhi |
| Address |
Department of Psychiatry, All India Institute of Medical Science, New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shaurya |
Department of Psychiatry, All India Institute of Medical Science, New Delhi |
Psychiatry Ward and OPD, Department of Psychiatry, All India Institute of Medical Science, New Delhi
New Delhi
DELHI |
9871905372
shaurya0398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for DBS surgery as selected by the neurology team criteria for which is
Diagnosis of idiopathic PD
Patient on more than 4 years of dopamine therapy
Presence of motor fluctuations and drug-related dyskinesia
Age 18- 70 will be included.
Absence of dementia or severe cognitive impairment (HMSE score more than 23)
Any gender
Willing to give written informed consent
Patient with good psychosocial support
|
|
| ExclusionCriteria |
| Details |
Leads removed due to infection, malfunction, etc
Suffering from any other severe psychiatric disorder or substance use disorder (except caffeine & nicotine) assessed through clinical interview
Comorbid neurological illness (e.g., stroke, TBI, SOL)
Uncontrolled medical illness (e.g., diabetes, hypertension)
Severe autonomic dysfunction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To examine the differences in psychiatric assessment between Parkinsons disease patients undergoing STN DBS and those not undergoing this procedure |
At baseline and at 6 months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the changes in PDQL (quality of life) post DBS |
at baseline and 6 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The impact of Subthalamic Nucleus Deep Brain Stimulation (STN-DBS) on psychiatric symptoms in Parkinson’s Disease (PD) remains an area of uncertainty, despite notable improvements in motor symptoms reported in the literature. The existing body of research presents mixed results regarding the effect of STN-DBS on psychiatric symptoms. Furthermore, there is a paucity of studies from India specifically examining the changes in neuropsychiatric symptoms following STN DBS in PD. In light of these gaps in knowledge, the current study is strategically designed to address this void and comprehensively assess the alterations in psychiatric symptoms subsequent to Deep Brain Stimulation of the Subthalamic Nucleus in individuals diagnosed with Parkinson’s Disease. This research aims to contribute valuable insights to the understanding of the holistic impact of STN-DBS, particularly in the context of neuropsychiatric manifestations in Parkinson’s Disease. Primary objective • To study the psychiatric changes at 6 months after bilateral STN-DBS in patients with Parkinson’s disease Secondary Objective • To study the effect of DBS on quality of life in patients with Parkinson’s disease Patients diagnosed with Parkinson’s disease, presenting at an outpatient facility in the Department of Neurology, All India Institute of Medical Science, New Delhi, will be included in the study. Patients diagnosed with Parkinson’s disease, would be selected for a Deep Brain Stimulation (DBS) procedure based on predefined inclusion/exclusion criteria. The study will include a minimum of 30 patients, calculated based on the feasibility of sampling using a convenience-based purposive sampling method. In the first group, a minimum of 20 selected patients will undergo the deep brain stimulation procedure. In the second group, a minimum of 10 controls (age and duration-matched patients with Parkinson’s disease) will be included. Inclusion and exclusion criteria will be applied. Informed written consent will be obtained from selected participants, and the following scales will be used to assess the patient at baseline (within 1 week prior to DBS): sociodemographic and clinical variables, GMHAT, HAM-D, HAM-A, BPRS, YMRS, YBOCS, BIS, PDQ-L, UPDRS. 6 months following the completion of the DBS surgery (by the neurosurgery department), reassessment will be conducted using the instruments used in the initial assessment.
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