Movement DisordersNCT04810325
Brain Sensing in Neurological and Psychiatric Disorders
An observational study of Movement Disorders and Dystonia, run by University College, London.
Trial summary
High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders, Dystonia, Parkinson Disease
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Oct 2022
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with neurological disorders treated with deep brain stimulation devices capable of neurophysiologic recording
Who may be able to join
- Age>18 years
- Neurological or psychiatric disorder treated with a DBS system.
- Able to give informed consent
Who cannot join
- • Inability to tolerate OFF stimulation conditions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Electrophysiologic Brain Sensing Using Implanted DBS Systems in Neurological and Psychiatric Disorders
High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. obsessive compulsive disorder, depression, cluster headache, Tourette syndrome, epilepsy and eating disorders6-11. It is currently applied in a continuous fashion, using parameters set by the treating clinician. This approach is non-physiological, as it applies a constant, unchanging therapy to a dysfunctional neuronal system that would normally fluctuate markedly on a moment-by moment basis, depending on external stressors, cognitive load, physical activity and the timing of medication administration.
Fluctuations in physical symptoms reflect fluctuations in brain activity. Tracking and responding in real-time to these would allow personalised approaches to DBS through stimulating at appropriate intensities and only when necessary, thereby improving therapeutic efficacy, preserving battery life and potentially limiting side-effects12. Critical to the development of such adaptive/closed-loop DBS technologies is the identification of robust signals on which to base the delivery of variable high-frequency deep brain stimulation.
Read more
Local field potentials (LFPs), which are recordable through standard DBS electrodes, represent synchronous neuronal discharges within the basal ganglia. Different LFP signatures have been identified in different disorders, as well as in different clinical states within individual disorders. For example, low frequency LFPs in the Alpha/Theta ranges (4-12Hz) are frequently encountered in patients with Dystonia13,14, while both beta (12-30Hz) gamma (60-90Hz) band frequencies may be seen in Parkinson's disease, when the patient is OFF and dyskinetic, respectively15,16. Equally, suppression of these abnormal basal ganglia signals through medication administration or high-frequency DBS correlates with clinical improvement. As such, they represent attractive electrophysiologic biomarkers on which to base adaptive DBS approaches.
Until recently, neurophysiological assessments were purely a research tool, as they could only be recorded either intra-operatively or for a short period of time post-operatively using externalised DBS electrodes. However, advances in DBS technology now allow real-time LFP recordings to be simply and seamlessly obtained from fully implanted DBS systems e.g. Medtronic Percept PC.
In this study, we will evaluate a cohort of patients with movement disorders and other disorders of basal ganglia circuitry who have implanted DBS systems. Recordings of LFPs and/or non-invasive data such as EEG, limb muscle activation and movement (surface EMG and motion tracking) under various conditions (e.g. voluntary movement, ON/OFF medications, ON/OFF stimulation) will allow us to evaluate their utility as markers of underlying disease phenotype and severity and to assess their potential for use as electrophysiological biomarkers in adaptive DBS approaches. These evaluations in patients with DBS systems with and without LFP-sensing capabilities will take place during a single or multi-day evaluation (depending on patient preference and researcher availability). This study will advance not only the understanding of subcortical physiology in various disorders, but will also provide information about how neurophysiological and behavioural biomarkers can be used to inform personalised, precision closed-loop DBS approaches.
Read the detailed description
Both hyperkinetic and hypokinetic movement disorders are associated with abnormal spatiotemporal activity within the basal ganglia circuitry13,16,17. This can be assessed through measuring local field potentials (LFPs), which represent the product of synchronous neuronal activity at a given site (unsynchronized, random activity being essentially cancelled out)13. Numerous other disorders such as obsessive compulsive disorder, major depression, Tourette's syndrome, epilepsy, eating disorders and cluster headaches are also amenable to successful modulation using DBS6-11. These disorders likely also have unique, disease-specific electrophysiological signatures, the exact nature of which remains to be thoroughly defined. Abnormal electrophysiological activity is useful not only in delineating the pathophysiologic underpinnings of these disorders, but is central to the future development of adaptive DBS systems which respond in real-time to ameliorate pathological brain acticity12. Adaptive DBS may provide further clinical benefit beyond currently employed continuous DBS approaches, with only a fraction of the energy requirements12.
Studies using microelectrode recordings at the time of DBS lead placement as well as recordings from externalised DBS electrodes have identified distinct neurophysiological signatures within different disorders. Examples include excess beta-frequency oscillations in Parkinsonism, alpha and theta frequency oscillations in dystonia and gamma oscillations in dyskinesia. These neurophysiologic biomarkers of disease can be affected by the application of high-frequency DBS. Future closed-loop DBS systems may rely on real-time suppression of such abnormal basal ganglia activity.
LFPs in Parkinson's disease
A significant body of work has confirmed that beta-frequency oscillations, recorded from both the subthalamic nucleus and the internal portion of the globus pallidus, correlate with severity of bradykinesia and rigidity in Parkinson's disease13,16-18. These beta-frequency oscillations are coherent across simultaneous recordings in different nuclei of the same patient, implying that these represent a network-level dysfunction in Parkinson's disease16,19. The amplitude/power of abnormal beta-frequency LFPs correlates with the severity of motor impairment in Parkinson's disease15,18. Moreover, beta-frequency LFPs can be suppressed both by levodopa administration, or by the application of high-frequency DBS20,21; in both scenarios the degree of suppression in beta-oscillations correlates with the degree of clinical motor improvement. Beta oscillations may therefore represent an electrophysiological parkinsonian symptom correlate which can act as a biomarker of the motor state. Hence, they may be useful signals on which to base stimulation using adaptive DBS technologies. However, some observations, such as the suppression of beta frequency oscillations during periods of tremor, have cast doubt on the robustness of this potential biomarker.
Other LFP frequency alterations have also been observed to correlate with clinical symptomatology in PD. For instance, synchronisation at frequencies in the gamma range (60-90Hz) have been correlated with dyskinesia, as have synchronisation at lower frequencies (4-8Hz)22,23. High-frequency oscillations in the 250Hz range have also been found to associate with parkinsonian clinical states and to shift to even higher frequencies (350Hz) following levodopa administration24. In contrast to beta-frequencies, changes in high-frequency LFPs do appear to correlate with tremor25.
Aside from pure frequency characteristics, the temporal distribution of beta-frequency oscillations has also been examined in different disease states. It is suggested that prolonged periods of beta synchronisation (beta bursts) may be responsible for the overall increase in beta power in patients with Parkinson's disease in the OFF state, and that a move to shorter durations of synchronisation may occur in the ON state26.
LFPs in dystonia
Patients with dystonia display a distinct pattern of LFP alterations in the pallidum13,14, particularly an excess of synchronized oscillatory activity in the low frequency 3-12 Hz band13. Not only is pallidal LFP power prominent in the 3-12Hz band in patients with dystonia13,27 but it correlates with28 and may be coherent with (especially contralateral) dystonic muscular activity29. Moreover, there is a direct association between pallidal low-frequency oscillations and dystonia severity30.
Increased LFP power in the low-frequency band is seen across a variety of dystonia phenotypes. In cervical dystonia, inter-hemispheric differences in LFPs have been demonstrated, though clear correlations with directional head movements have not been established31,32. In myoclonus-dystonia patients, increased pallidal LFP in the 3-15Hz range correlate with dystonic muscle activity33. Oscillatory activity may be different in secondary or combined dystonia, and may also differ according to genetic makeup 34-36.
LFPs in essential tremor
LFP recordings from patients undergoing thalamic DBS in ET have identified distinct thalamic LFP frequency characteristics, often coherent with surface EMG recordings in these groups, at frequencies which are either harmonics or subharmonics of the tremor frequency37.
LFPs in other conditions Electrophysiologic recordings from patients with Tourette's syndrome have shown an excess of low-frequency activity(2-13Hz) in both thalamic and pallidal targets38 and that spontaneous tics in Tourette's syndrome are preceded by coherent thalamo-cortical discharges39. Unique, disease specific LFP patterns have also been identified in a number of neuropsychiatric disorders. For example, prominent alpha activity in the basal ganglia has been suggested as an electrophysiologic correlate of major depressive disorders40
Continuous recording from fully implanted DBS systems has only recently become possible, for example using the Medtronic Percept PC battery system. The quality of signals recorded using this system as well as the correlation with clinical features, and coherence with cortical and motor activity however remain largely unexplored. Moreover, the number of patients on which previous LFP studies has been based is small. Hence, their utility in the future development of closed-loop DBS systems remains uncertain.
Our study will address a number of unanswered questions relating to the utility of LFP recordings in neurological disorders including:
- Is it possible to replicate the previous findings concerning LFP signatures in various movement disorders using currently available DBS systems with LFP sensing capabilities e.g. Medtronic Percept PC?
- Do LFP signatures persist many years after initiation of deep brain stimulation (most previous studies have evaluated patients only at the time of DBS implantation)?
- How are LFP signatures related to modulations of wider brain networks as assessed by EEG?
- Can non-invasive recording methods such as EEG provide alternative or complementary biomarkers for closed-loop DBS?
- What is the influence of medications, body movements, sensory inputs and differential stimulation parameters on LFPs?
- How robust are LFP signatures within and between individuals with similar disease states?
- Do robust LFP signatures exist for non movement disorder basal ganglia network pathologies, and how do these correlate with symptoms severity?
- Conditions
- Movement Disorders, Dystonia, Parkinson Disease, Tremor
- Medical subject headings
- Movement Disorders, Dystonia, Parkinson Disease, Tremor
What is being measured
The primary outcome is the main question the study is designed to answer.
local field potential power (amplitude)
Measured: 12 months
local field potential frequency (Hz)
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 posted22 Mar 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by University 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
- Cross-sectional
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricia Limousin, PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810325
- Sponsor's protocol ID
- 296010
- Status last verified
- May 2021
- First submitted
- 1 Mar 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologic Brain Sensing Using Implanted DBS Systems in Neurological and Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT04810325
- Acronym / sponsor ID
- 296010
- Conditions
- Movement Disorders, Dystonia, Parkinson Disease, Tremor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 22 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.
High-frequency deep brain stimulation (DBS) is an effective treatment strategy for a variety of movement disorders including Parkinson's disease, dystonia and tremor1-5, as well as for other neurological and psychiatric disorders e.g. obsessive compulsive disorder, depression, cluster headache, Tourette syndrome, epilepsy and eating disorders6-11. It is currently applied in a continuous fashion, using parameters set by the treating clinician. This approach is non-physiological, as it applies a constant, unchanging therapy to a dysfunctional neuronal system that would normally fluctuate markedly on a moment-by moment basis, depending on external stressors, cognitive load, physical activity and the timing of medication administration.
Fluctuations in physical symptoms reflect fluctuations in brain activity. Tracking and responding in real-time to these would allow personalised approaches to DBS through stimulating at appropriate intensities and only when necessary, thereby improving therapeutic efficacy, preserving battery life and potentially limiting side-effects12. Critical to the development of such adaptive/closed-loop DBS technologies is the identification of robust signals on which to base the delivery of variable high-frequency deep brain stimulation.
Local field potentials (LFPs), which are recordable through standard DBS electrodes, represent synchronous neuronal discharges within the basal ganglia. Different LFP signatures have been identified in different disorders, as well as in different clinical states within individual disorders. For example, low frequency LFPs in the Alpha/Theta ranges (4-12Hz) are frequently encountered in patients with Dystonia13,14, while both beta (12-30Hz) gamma (60-90Hz) band frequencies may be seen in Parkinson's disease, when the patient is OFF and dyskinetic, respectively15,16. Equally, suppression of these abnormal basal ganglia signals through medication administration or high-frequency DBS correlates with clinical improvement. As such, they represent attractive electrophysiologic biomarkers on which to base adaptive DBS approaches.
Until recently, neurophysiological assessments were purely a research tool, as they could only be recorded either intra-operatively or for a short period of time post-operatively using externalised DBS electrodes. However, advances in DBS technology now allow real-time LFP recordings to be simply and seamlessly obtained from fully implanted DBS systems e.g. Medtronic Percept PC.
In this study, we will evaluate a cohort of patients with movement disorders and other disorders of basal ganglia circuitry who have implanted DBS systems. Recordings of LFPs and/or non-invasive data such as EEG, limb muscle activation and movement (surface EMG and motion tracking) under various conditions (e.g. voluntary movement, ON/OFF medications, ON/OFF stimulation) will allow us to evaluate their utility as markers of underlying disease phenotype and severity and to assess their potential for use as electrophysiological biomarkers in adaptive DBS approaches. These evaluations in patients with DBS systems with and without LFP-sensing capabilities will take place during a single or multi-day evaluation (depending on patient preference and researcher availability). This study will advance not only the understanding of subcortical physiology in various disorders, but will also provide information about how neurophysiological and behavioural biomarkers can be used to inform personalised, precision closed-loop DBS approaches.
Detailed description
Both hyperkinetic and hypokinetic movement disorders are associated with abnormal spatiotemporal activity within the basal ganglia circuitry13,16,17. This can be assessed through measuring local field potentials (LFPs), which represent the product of synchronous neuronal activity at a given site (unsynchronized, random activity being essentially cancelled out)13. Numerous other disorders such as obsessive compulsive disorder, major depression, Tourette's syndrome, epilepsy, eating disorders and cluster headaches are also amenable to successful modulation using DBS6-11. These disorders likely also have unique, disease-specific electrophysiological signatures, the exact nature of which remains to be thoroughly defined. Abnormal electrophysiological activity is useful not only in delineating the pathophysiologic underpinnings of these disorders, but is central to the future development of adaptive DBS systems which respond in real-time to ameliorate pathological brain acticity12. Adaptive DBS may provide further clinical benefit beyond currently employed continuous DBS approaches, with only a fraction of the energy requirements12.
Studies using microelectrode recordings at the time of DBS lead placement as well as recordings from externalised DBS electrodes have identified distinct neurophysiological signatures within different disorders. Examples include excess beta-frequency oscillations in Parkinsonism, alpha and theta frequency oscillations in dystonia and gamma oscillations in dyskinesia. These neurophysiologic biomarkers of disease can be affected by the application of high-frequency DBS. Future closed-loop DBS systems may rely on real-time suppression of such abnormal basal ganglia activity.
LFPs in Parkinson's disease
A significant body of work has confirmed that beta-frequency oscillations, recorded from both the subthalamic nucleus and the internal portion of the globus pallidus, correlate with severity of bradykinesia and rigidity in Parkinson's disease13,16-18. These beta-frequency oscillations are coherent across simultaneous recordings in different nuclei of the same patient, implying that these represent a network-level dysfunction in Parkinson's disease16,19. The amplitude/power of abnormal beta-frequency LFPs correlates with the severity of motor impairment in Parkinson's disease15,18. Moreover, beta-frequency LFPs can be suppressed both by levodopa administration, or by the application of high-frequency DBS20,21; in both scenarios the degree of suppression in beta-oscillations correlates with the degree of clinical motor improvement. Beta oscillations may therefore represent an electrophysiological parkinsonian symptom correlate which can act as a biomarker of the motor state. Hence, they may be useful signals on which to base stimulation using adaptive DBS technologies. However, some observations, such as the suppression of beta frequency oscillations during periods of tremor, have cast doubt on the robustness of this potential biomarker.
Other LFP frequency alterations have also been observed to correlate with clinical symptomatology in PD. For instance, synchronisation at frequencies in the gamma range (60-90Hz) have been correlated with dyskinesia, as have synchronisation at lower frequencies (4-8Hz)22,23. High-frequency oscillations in the 250Hz range have also been found to associate with parkinsonian clinical states and to shift to even higher frequencies (350Hz) following levodopa administration24. In contrast to beta-frequencies, changes in high-frequency LFPs do appear to correlate with tremor25.
Aside from pure frequency characteristics, the temporal distribution of beta-frequency oscillations has also been examined in different disease states. It is suggested that prolonged periods of beta synchronisation (beta bursts) may be responsible for the overall increase in beta power in patients with Parkinson's disease in the OFF state, and that a move to shorter durations of synchronisation may occur in the ON state26.
LFPs in dystonia
Patients with dystonia display a distinct pattern of LFP alterations in the pallidum13,14, particularly an excess of synchronized oscillatory activity in the low frequency 3-12 Hz band13. Not only is pallidal LFP power prominent in the 3-12Hz band in patients with dystonia13,27 but it correlates with28 and may be coherent with (especially contralateral) dystonic muscular activity29. Moreover, there is a direct association between pallidal low-frequency oscillations and dystonia severity30.
Increased LFP power in the low-frequency band is seen across a variety of dystonia phenotypes. In cervical dystonia, inter-hemispheric differences in LFPs have been demonstrated, though clear correlations with directional head movements have not been established31,32. In myoclonus-dystonia patients, increased pallidal LFP in the 3-15Hz range correlate with dystonic muscle activity33. Oscillatory activity may be different in secondary or combined dystonia, and may also differ according to genetic makeup 34-36.
LFPs in essential tremor
LFP recordings from patients undergoing thalamic DBS in ET have identified distinct thalamic LFP frequency characteristics, often coherent with surface EMG recordings in these groups, at frequencies which are either harmonics or subharmonics of the tremor frequency37.
LFPs in other conditions Electrophysiologic recordings from patients with Tourette's syndrome have shown an excess of low-frequency activity(2-13Hz) in both thalamic and pallidal targets38 and that spontaneous tics in Tourette's syndrome are preceded by coherent thalamo-cortical discharges39. Unique, disease specific LFP patterns have also been identified in a number of neuropsychiatric disorders. For example, prominent alpha activity in the basal ganglia has been suggested as an electrophysiologic correlate of major depressive disorders40
Continuous recording from fully implanted DBS systems has only recently become possible, for example using the Medtronic Percept PC battery system. The quality of signals recorded using this system as well as the correlation with clinical features, and coherence with cortical and motor activity however remain largely unexplored. Moreover, the number of patients on which previous LFP studies has been based is small. Hence, their utility in the future development of closed-loop DBS systems remains uncertain.
Our study will address a number of unanswered questions relating to the utility of LFP recordings in neurological disorders including:
- Is it possible to replicate the previous findings concerning LFP signatures in various movement disorders using currently available DBS systems with LFP sensing capabilities e.g. Medtronic Percept PC?
- Do LFP signatures persist many years after initiation of deep brain stimulation (most previous studies have evaluated patients only at the time of DBS implantation)?
- How are LFP signatures related to modulations of wider brain networks as assessed by EEG?
- Can non-invasive recording methods such as EEG provide alternative or complementary biomarkers for closed-loop DBS?
- What is the influence of medications, body movements, sensory inputs and differential stimulation parameters on LFPs?
- How robust are LFP signatures within and between individuals with similar disease states?
- Do robust LFP signatures exist for non movement disorder basal ganglia network pathologies, and how do these correlate with symptoms severity?
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with neurological disorders treated with deep brain stimulation devices capable of neurophysiologic recording
Key inclusion criteria (3 listed)
- Age>18 years
- Neurological or psychiatric disorder treated with a DBS system.
- Able to give informed consent
Key exclusion criteria (1 listed)
- • Inability to tolerate OFF stimulation conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
local field potential power (amplitude)
Time frame: 12 months
local field potential frequency (Hz)
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 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Patricia Limousin, PhD principal investigator
UCL
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders and Dystonia, run by University 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 3 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 May 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?
Contact Patricia Limousin, PhD (00442034567890, p.limousin@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
local field potential power (amplitude) (time frame: 12 months). The study lists 2 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 May 2021.