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| Name | Class |
|---|---|
| South London and Maudsley NHS Foundation Trust | OTHER |
| NHS Greater Glasgow and Clyde | OTHER |
| King's College Hospital NHS Trust | OTHER |
| Walton Centre NHS Foundation Trust |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subthalamic Nucleaus Deep brain stimulation | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in severity of ICBs and development of new ICBs | 12 months | |
| Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs | 12 months | |
| Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| predictive factors for de novo, recurrence and change in severity of ICD/ICBs | 12 months | |
| change in ICB relate to quality of life in patients and carers | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| OTHER |
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| Barking, Havering and Redbridge University Hospitals NHS Trust | OTHER |
| Northern Care Alliance NHS Foundation Trust | OTHER |
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| change in ICD relates to changes in mood |
| 12 months |
| change in ICD relates to change in personality traits | 12 months |
| ID | Term |
|---|---|
| D007175 | Impulsive Behavior |
| D005715 | Gambling |
| D002032 | Bulimia |
| D000067836 | Hoarding Disorder |
| D000096583 | Compulsive Sexual Behavior Disorder |
| D000084802 | Caregiver Burden |
| D010300 | Parkinson Disease |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D060845 | Hoarding |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012309 | Risk-Taking |
| D001523 | Mental Disorders |
| D006963 | Hyperphagia |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009771 | Obsessive-Compulsive Disorder |
| D001008 | Anxiety Disorders |
| D016739 | Behavior, Addictive |
| D003192 | Compulsive Behavior |
| D019968 | Sexual and Gender Disorders |
| D020018 | Sexual Dysfunctions, Psychological |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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