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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04811807
Other study ID # 285162
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2021
Est. completion date November 2024

Study information

Verified date March 2021
Source King's College London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The objective of this prospective observational cohort study is to answer the following clinically important questions: 1. In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively? 2. What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)? 3. Which factors are important in predicting changes in ICBs after STN DBS? 4. What is the impact of ICBs on carer's quality of life QoL and burden?


Description:

The study will record outcomes related to ICBs for PD patients who have already been selected for DBS therapy as a routine clinical treatment in participating in DBS operating centre It is routine practice to assess ICBs before DBS decisions are made, but the manner varies across DBS operating centres. The only additional factor to the routine DBS clinical pathway in this study is that the centres involved will perform assessments in a uniform manner to allow data to be combined. A unified set of clinical assessment scales for Impulsive Control Disorders ICDs and ICBs, as well as other relevant neuropsychiatric symptom assessment, will be added to routine pre- and post-operational clinical assessments for participants. The primary endpoint of the study is the change in severity of ICBs. If subjects score above 1 in any of given questions on QUIP-RS, or if subjects had disagreement with carers regarding scores, The Parkinson's Impulse-Control Scale, PICs will be triggered. PICs then will be administered by our trained research fellow (AA), over phone or in the clinic. Other scales to be administered are listed below: 1. Neuropsychiatric Inventory (NPI) 2. General anxiety disorder-7 (GAD-7) 3. Patient Health Questionnaire-9 (PHQ9) 4. Parkinson's disease questionnaire-39 (PDQ-39) 5. EuroQol 5 Dimension (EQ-5D) 6. Clinical Global Impression - Severity scale (CGI-S) at baseline and Clinician's Global Impression - Improvement scale (GGI-I) post-operatively. 7. Zarit Caregiver Burden Scale 8. Work and Social Adjustment Scale 9. UPPS-P Impulsive Behaviour Scale Assessments will be performed at baseline, 3, 6 and 12 months post-operatively. Results will be analysed to ascertain potential predictive measures for ICBS development/change.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Selected for DBS to treat motor symptoms of Parkinson's disease - English language fluency Exclusion Criteria: - nil

Study Design


Intervention

Device:
Subthalamic Nucleaus Deep brain stimulation
In deep brain stimulation (DBS) therapy, a specific anatomical target in the brain is stimulated via surgically fixed electrodes. These electrodes release electrical currents of a specific voltage, wavelength, and frequency. They are connected via subcutaneous wires to a device called an implantable pulse generator (IPG) which is surgically fixed on chest wall, beneath the clavicle. After electrodes and IPG are successfully installed, a clinician will be able to adjust and modulate the stimulation via a remote device connected to the IPG to obtain a maximum potential benefit. Deep brain stimulation has been used in clinics to treat various neurologic diseases including neurodegenerative disorders, mainly movement disorders.

Locations

Country Name City State
n/a

Sponsors (9)

Lead Sponsor Collaborator
King's College London Barking, Havering and Redbridge University Hospitals NHS Trust, King's College Hospital NHS Trust, Newcastle-upon-Tyne Hospitals NHS Trust, NHS Greater Glasgow and Clyde, Oxford University Hospitals NHS Trust, Salford Royal NHS Foundation Trust, South London and Maudsley NHS Foundation Trust, Walton Centre NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary change in severity of ICBs and development of new ICBs 12 months
Primary Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs 12 months
Primary Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs 12 months
Secondary predictive factors for de novo, recurrence and change in severity of ICD/ICBs 12 months
Secondary change in ICB relate to quality of life in patients and carers 12 months
Secondary change in ICD relates to changes in mood 12 months
Secondary change in ICD relates to change in personality traits 12 months
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