An observational study in Impulsive Behavior, Impulse Disorders and Gambling, Pathological, sponsored by King's College London. Status unknown. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by King's College London · Observational
The objective of this prospective observational cohort study is to answer the following clinically important questions:
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:
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.
158 studies on the registry are indexed under Impulsive Behavior; 31 are open to participants now.
This study's planned enrollment of 50 is below the median of 120 across 24 observational studies indexed under Impulsive Behavior.
Browse Impulsive Behavior studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All potential participants will have been selected by their clinicians for DBS to treat their motor symptoms as routine clinical care. They will be approached during their hospital appointment by their clinical care team, who will be the research link to this study, principal investigator
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: DBS, Brain stimulation
change in severity of ICBs and development of new ICBs
Time frame: 12 months
Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs
Time frame: 12 months
Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs
Time frame: 12 months
predictive factors for de novo, recurrence and change in severity of ICD/ICBs
Time frame: 12 months
change in ICB relate to quality of life in patients and carers
Time frame: 12 months
change in ICD relates to changes in mood
Time frame: 12 months
change in ICD relates to change in personality traits
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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