Impulsive BehaviorCRIPSNCT04811807
Clinical Response of Impulsivity After Brain Stimulation in Parkinson's Disease
An observational study of Impulsive Behavior and Impulse Disorders, run by King's College London.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Impulsive Behavior, Impulse Disorders, Gambling, Pathological
- What is being tested?
- Subthalamic Nucleaus Deep brain stimulation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Nov 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- Selected for DBS to treat motor symptoms of Parkinson's disease
- English language fluency
Who cannot join
- nil
About this study
Official title: Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease
The objective of this prospective observational cohort study is to answer the following clinically important questions:
- In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively?
- What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)?
- Which factors are important in predicting changes in ICBs after STN DBS?
- What is the impact of ICBs on carer's quality of life QoL and burden?
Read the detailed 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:
- Neuropsychiatric Inventory (NPI)
- General anxiety disorder-7 (GAD-7)
- Patient Health Questionnaire-9 (PHQ9)
- Parkinson's disease questionnaire-39 (PDQ-39)
- EuroQol 5 Dimension (EQ-5D)
- Clinical Global Impression - Severity scale (CGI-S) at baseline and Clinician's Global Impression - Improvement scale (GGI-I) post-operatively.
- Zarit Caregiver Burden Scale
- Work and Social Adjustment Scale
- 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.
- Conditions
- Impulsive Behavior, Impulse Disorders, Gambling, Pathological, Eating, Binge, Hoarding Disorder, Hypersexuality
- Being tested
- Subthalamic Nucleaus Deep brain stimulation
- Keywords
- Deep brain stimulation, Parkinson's disease, Impulse control disorders, Impulse control behaviours, compulsive shopping, hypersexuality, binge eating, gambling, walkabouts, hobbyism, Hoarding, punding
- Medical subject headings
- Impulsive Behavior, Gambling, Bulimia, Hoarding Disorder, Compulsive Sexual Behavior Disorder, Caregiver Burden, Parkinson Disease, Disruptive, Impulse Control, and Conduct Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthalamic Nucleaus Deep brain stimulationDevice
Also called DBS, 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
change in severity of ICBs and development of new ICBs
Measured: 12 months
Descriptive analysis of recurrence of ICBs in those with history of ICBs using scores on QUIP-RS/PICs
Measured: 12 months
Descriptive analysis of de novo cases of Impulsive control disorders ICD/ICBs
Measured: 12 months
Secondary outcomes (4)
predictive factors for de novo, recurrence and change in severity of ICD/ICBs
Measured: 12 months
change in ICB relate to quality of life in patients and carers
Measured: 12 months
change in ICD relates to changes in mood
Measured: 12 months
change in ICD relates to change in personality traits
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impulsive BehaviorStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, NHS Greater Glasgow and Clyde, King's College Hospital NHS Trust, Walton Centre NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811807
- Sponsor's protocol ID
- 285162
- Acronym
- CRIPS
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Observational Study of Impulsive Behaviours Following Deep Brain Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04811807
- Acronym / sponsor ID
- CRIPS / 285162
- Conditions
- Impulsive Behavior, Impulse Disorders, Gambling, Pathological, Eating, Binge, Hoarding Disorder, Hypersexuality
- Keywords
- Deep brain stimulation, Parkinson's disease, Impulse control disorders, Impulse control behaviours, compulsive shopping, hypersexuality, binge eating, gambling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust, NHS Greater Glasgow and Clyde, King's College Hospital NHS Trust, Walton Centre NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Oxford University Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust, Northern Care Alliance NHS Foundation Trust
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this prospective observational cohort study is to answer the following clinically important questions:
- In patients with a pre-operative history of ICBs, what is the likelihood of improvement or deterioration in ICBs post-operatively?
- What is the risk of developing post-operative de novo ICBs after Subthalamic Nucleus DBS (STN DBS)?
- Which factors are important in predicting changes in ICBs after STN DBS?
- What is the impact of ICBs on carer's quality of life QoL and burden?
Detailed 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:
- Neuropsychiatric Inventory (NPI)
- General anxiety disorder-7 (GAD-7)
- Patient Health Questionnaire-9 (PHQ9)
- Parkinson's disease questionnaire-39 (PDQ-39)
- EuroQol 5 Dimension (EQ-5D)
- Clinical Global Impression - Severity scale (CGI-S) at baseline and Clinician's Global Impression - Improvement scale (GGI-I) post-operatively.
- Zarit Caregiver Burden Scale
- Work and Social Adjustment Scale
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- Selected for DBS to treat motor symptoms of Parkinson's disease
- English language fluency
Key exclusion criteria (1 listed)
- nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subthalamic Nucleaus Deep brain stimulationAlso: DBS, Brain stimulationIn 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. | Device | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Impulsive Behavior and Impulse Disorders, run by King's College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in severity of ICBs and development of new ICBs (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.