Parkinson DiseaseINSHAPE_DBSNCT04725045
Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders
A study testing Boston Scientific: Study tool computer in people with Parkinson Disease and Essential Tremor, run by KU Leuven at 1 site in Belgium.
Trial summary
Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease, Essential Tremor
- What is being tested?
- Boston Scientific: Study tool computer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Feb 2019to 14 Apr 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease where the diagnosis was made by a Movement Disorder Specialist according to the MDS criteria of 2015, with a Hoehn and Yahr scale (H\&Y) of at least 2 (bilateral involvement).
- Onset of the symptoms more than five years ago.
- MDS-UPDRS-III score of ≥30 without medication or DBS.
- Electrodes are implanted in target area STN.
- Patient is diagnosed with essential tremor by a Movement Disorder Specialist.
- Diagnosis since more than 3 years.
Show all 16Show fewer
- Patient has a disabling medical-refractory upper extremity tremor without medication or DBS.
- Patient has a postural or kinetic tremor severity score of at least 3 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor without medication or DBS.
- Electrodes are implanted in target area VIM.
- General Inclusion Criteria:
- Post-op the implanted electrodes pass an integrity check, i.e. no open or shorted electrodes.
- Stable medications
- Lack of dementia or depression.
- Patient is willing and able to comply with all visits and study related procedures
- Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
- Patient can tolerate at least 12 hours OFF medication and per clinical judgement be able to perform all study related procedures
Who cannot join
- Any significant psychiatric problems, including unrelated clinically significant depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out from the electrode creating a broad, electric field that stimulates a large neural population. This can often effectively reduce motor symptoms. However, many DBS patients experience side effects - caused by stimulation of non-target neurons - and suboptimal symptom control - caused by inadequate stimulation of the correct neural target. The ability to carefully manipulate the stimulating electric field to target specific neural subpopulations could solve these problems and improve patient outcomes. The use of complex pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the temporal properties of the stimulation field. Evidence suggests that temporal manipulations of the stimulation field can exploit biophysical differences in neurons to target specific subpopulations. Therefore, our aim is to evaluate the effectiveness of complex pulse shapes to reduce side effects and improve symptom control in DBS movement patients.
Read the detailed description
The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed.
Stage 2 will perform a short-term chronic evaluation in a larger number of patients of the complex pulse shape selected as most interesting from stage 1.
- ET patients will first be assessed after 3 hours of the cathodic or complex pulse (double-blind design).
- PD patients will only be assessed after 1 week of each pulse.
Stage 3 will then focus on long-term evaluation (upto 2 years). Outcomes: see stage 2.
- Conditions
- Parkinson Disease, Essential Tremor
- Being tested
- Boston Scientific: Study tool computer
- Medical subject headings
- Parkinson Disease, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Scientific: Study tool computerDevice
compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape
| Study group | Role | What they receive |
|---|---|---|
| Standard clinical pulse shape | Active comparator | Standard clinical pulse shape as used in clinical practice (cathodic stimulation). Receives: Device: Boston Scientific: Study tool computer |
| Complex pulse shape | Experimental | Complex pulse shape (i.e. biphasic pulse shape anode first, biphasic pulse shape cathode first, hyperpolarizing pre-pulse or depolarizing pre-pulse) Receives: Device: Boston Scientific: Study tool computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Therapeutic window = Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
Measured: Immediately after testing
Stage 2 ET (3 hours): tremor scores
FTM (Fahn-Tolosa-Marin) total score. Max 116 (higher score for more tremor).
Measured: Measured after 3 hours of stimulation
Stage 2 ET (3 hours): ataxia scores
ICARS (International cooperative ataxia rating scale): total score. Max 100 (higher score for more ataxia).
Measured: Measured after 3 hours of stimulation
Stage 2 ET (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
Follow-up of (S)AE related to the study during that week
Measured: During 1 week of stimulation
Stage 2 PD (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
Follow-up of (S)AE related to the study during that week
Measured: During 1 week of stimulation
Stage 3 ET (2 years): number of treatment-related adverse events as assessed by CTCAE v4.0
Follow-up of (S)AE related to the study during those 2 years
Measured: During 2 years of stimulation
Secondary outcomes (22)
Stage 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Follow-up of (S)AE related to the study upto 1 week after the experiment
Measured: Upto one week after the study visit of stage 1
Stage 2 ET (3 hours): Therapeutic window: Amplitude to elicit tremor arrest, amplitude to elicit ataxia, amplitude to elicit stim-induced side-effects
Amplitude to elicit tremor arrest, amplitude to elicit ataxia, amplitude to elicit stimulation-induced side-effects (all expressed in mA)
Measured: Immediately after testing
Stage 2 ET (3 hours): tremor subscores
FTM (Fahn-Tolosa-Marin) subscores: items 5, 6, 11, 12 and 13 (max 48, higher score for more tremor)
Measured: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (3 hours): ataxia subscores
ICARS (international cooperative ataxia rating scale): item 10 (max 8, higher score for more ataxia)
Measured: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (3 hours): speech assessment (least dysarthria)
Tests: sustained phonation /a/, diadochokinesis /tatata/, text reading and spontaneous speech Outcome: which of both pulses has less dysarthria per test (either cathodic pulse, either experimental pulse)
Measured: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (1 week): tremor scores and subscores
FTM (Fahn-Tolosa-Marin) tremor rating scale:
- total score (max 116, higher score for more tremor)
- subscores: items 5, 6, 11, 12 and 13 (max 48, higher score for more tremor)
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): ataxia subscores and total score
ICARS (international cooperative ataxia rating scale):
- total score: max 100, higher score for more ataxia
- subscore: item 10 (max 8, higher score for more ataxia)
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): tremor measured with Kinesia One wearable
Amount of postural tremor and kinetic tremor in both hands (max 4 per side, higher score for more tremor)
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): tremor time measured with Kinesia 360
Amount of tremor time measured with Kinesia 360 wearable (%, higher score for more tremor time)
Measured: Measured during 1 week of stimulation
Stage 2 ET (1 week): speech assessment (least dysarthria)
Tests: sustained phonation /a/, diadochokinesis /tatata/, text reading and spontaneous speech Outcome: which of both pulses has less dysarthria per test (either cathodic pulse, either experimental pulse)
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): cognition
MoCA (Montreal Cognitive Assessment). Max 30, higher score for better cognition.
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): quality-of-life
QUEST (Quality-of-life in essential tremor questionnaire). Max 100%, higher score for worse quality-of-life.
Measured: Measured after 1 week of stimulation
Stage 2 ET (1 week): quality-of-life
VAS (visual analogue scale) for:
- amount of tremor
- discomfort due to tremor Max 10, higher scores for worse outcome.
Measured: Measured once daily during 1 week of stimulation
Stage 2 PD (1 week): therapeutic window (amplitude at loss of rigidity and amplitude at stim-induced side-effects)
Amplitude at loss of rigidity and amplitude at stimulation-induced side-effects
Measured: Immediately after testing
Stage 2 PD (1 week): assessment motor symptoms in Parkinson's
MDS-UPDRS-III (Movement Disorders Society Unified Parkinson's Disease Rating Scale, part III). Max 132, higher score for more parkinsonian symptoms.
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment non-motor symptoms in Parkinson's
NMSS (non-motor symptoms scale). Max 30, higher scores for more symptoms.
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment of motor symptoms in Parkinson's with Kinesia One wearable
Wearable scores finger tapping and hand opening. Max 4 per item, higher scores for more symptoms.
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment motor symptoms in Parkinson's with Kinesia 360 wearable
Wearable score amount of time that patient was bradykinetic and dyskinetic. Expressed as %, higher scores for more symptoms
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment of speech (least dysarthria)
Tests: sustained phonation /a/, diadochokinesis /tatata/, text reading and spontaneous speech Outcome: which of both pulses has less dysarthria per test (either cathodic pulse, either experimental pulse)
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): cognition
MoCA (Montreal Cognitive Assessment). Max 30, higher score for better cognition.
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): quality-of-life
PDQ-39 (Parkinson's disease Questionnaire): 39-item questionnaire on quality-of-life.
Expressed in %, higher score for more symptoms.
Measured: Measured after 1 week of stimulation
Stage 2 PD (1 week): quality-of-life
VAS (visual analogue scale) for:
- amount of parkinsonian symptoms
- discomfort due to parkinsonian symptoms Max 10, higher scores for worse outcome.
Measured: Measured once daily during 1 week of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start12 Feb 2019
- Primary completion14 Apr 2022
- Study completion14 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, crossover, double-blinded design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myles Mc Laughlin, KU Leuven
- Investigators
- Myles Mc Laughlin, Prof. Dr., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725045
- Sponsor's protocol ID
- S61020
- Acronym
- INSHAPE_DBS
- Status last verified
- Apr 2022
- First submitted
- 24 Nov 2020
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders
- ClinicalTrials.gov ID
- NCT04725045
- Acronym / sponsor ID
- INSHAPE_DBS / S61020
- Conditions
- Parkinson Disease, Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 14 Apr 2022 (actual)
- Study completion
- 14 Apr 2022 (actual)
- First posted
- 26 Jan 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.
Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out from the electrode creating a broad, electric field that stimulates a large neural population. This can often effectively reduce motor symptoms. However, many DBS patients experience side effects - caused by stimulation of non-target neurons - and suboptimal symptom control - caused by inadequate stimulation of the correct neural target. The ability to carefully manipulate the stimulating electric field to target specific neural subpopulations could solve these problems and improve patient outcomes. The use of complex pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the temporal properties of the stimulation field. Evidence suggests that temporal manipulations of the stimulation field can exploit biophysical differences in neurons to target specific subpopulations. Therefore, our aim is to evaluate the effectiveness of complex pulse shapes to reduce side effects and improve symptom control in DBS movement patients.
Detailed description
The study had three stages. In the first stage, a wide range of investigatory pulse shapes in a small number of patients. The effect of the pulses on the therapeutic window will be assessed.
Stage 2 will perform a short-term chronic evaluation in a larger number of patients of the complex pulse shape selected as most interesting from stage 1.
- ET patients will first be assessed after 3 hours of the cathodic or complex pulse (double-blind design).
- PD patients will only be assessed after 1 week of each pulse.
Stage 3 will then focus on long-term evaluation (upto 2 years). Outcomes: see stage 2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, crossover, double-blinded design
| Arm | Type | Receives |
|---|---|---|
| Standard clinical pulse shape | Active comparator | Device: Boston Scientific: Study tool computerStandard clinical pulse shape as used in clinical practice (cathodic stimulation). |
| Complex pulse shape | Experimental | Device: Boston Scientific: Study tool computerComplex pulse shape (i.e. biphasic pulse shape anode first, biphasic pulse shape cathode first, hyperpolarizing pre-pulse or depolarizing pre-pulse) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of idiopathic Parkinson's disease where the diagnosis was made by a Movement Disorder Specialist according to the MDS criteria of 2015, with a Hoehn and Yahr scale (H\&Y) of at least 2 (bilateral involvement).
- Onset of the symptoms more than five years ago.
- MDS-UPDRS-III score of ≥30 without medication or DBS.
- Electrodes are implanted in target area STN.
- Patient is diagnosed with essential tremor by a Movement Disorder Specialist.
Key exclusion criteria (4 listed)
- Any significant psychiatric problems, including unrelated clinically significant depression.
- Any current drug or alcohol abuse.
- Any history of recurrent or unprovoked seizures.
- Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival <12 months.
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 |
|---|---|---|
| Boston Scientific: Study tool computercompare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape | Device | Complex pulse shape, Standard clinical pulse shape |
Primary outcome
Stage 1: Therapeutic window = Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
Time frame: Immediately after testing
Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
Stage 2 ET (3 hours): tremor scores
Time frame: Measured after 3 hours of stimulation
FTM (Fahn-Tolosa-Marin) total score. Max 116 (higher score for more tremor).
Stage 2 ET (3 hours): ataxia scores
Time frame: Measured after 3 hours of stimulation
ICARS (International cooperative ataxia rating scale): total score. Max 100 (higher score for more ataxia).
Stage 2 ET (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: During 1 week of stimulation
Follow-up of (S)AE related to the study during that week
Stage 2 PD (1 week): number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: During 1 week of stimulation
Follow-up of (S)AE related to the study during that week
Stage 3 ET (2 years): number of treatment-related adverse events as assessed by CTCAE v4.0
Time frame: During 2 years of stimulation
Follow-up of (S)AE related to the study during those 2 years
22 secondary outcomes
Stage 1: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Upto one week after the study visit of stage 1
Stage 2 ET (3 hours): Therapeutic window: Amplitude to elicit tremor arrest, amplitude to elicit ataxia, amplitude to elicit stim-induced side-effects
Time frame: Immediately after testing
Stage 2 ET (3 hours): tremor subscores
Time frame: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (3 hours): ataxia subscores
Time frame: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (3 hours): speech assessment (least dysarthria)
Time frame: Measured at 1 hours, 2 hours and 3 hours after start of stimulation
Stage 2 ET (1 week): tremor scores and subscores
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): ataxia subscores and total score
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): tremor measured with Kinesia One wearable
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): tremor time measured with Kinesia 360
Time frame: Measured during 1 week of stimulation
Stage 2 ET (1 week): speech assessment (least dysarthria)
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): cognition
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): quality-of-life
Time frame: Measured after 1 week of stimulation
Stage 2 ET (1 week): quality-of-life
Time frame: Measured once daily during 1 week of stimulation
Stage 2 PD (1 week): therapeutic window (amplitude at loss of rigidity and amplitude at stim-induced side-effects)
Time frame: Immediately after testing
Stage 2 PD (1 week): assessment motor symptoms in Parkinson's
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment non-motor symptoms in Parkinson's
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment of motor symptoms in Parkinson's with Kinesia One wearable
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment motor symptoms in Parkinson's with Kinesia 360 wearable
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): assessment of speech (least dysarthria)
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): cognition
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): quality-of-life
Time frame: Measured after 1 week of stimulation
Stage 2 PD (1 week): quality-of-life
Time frame: Measured once daily during 1 week of stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- 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.
Myles Mc Laughlin, Prof. Dr. principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Scientific: Study tool computer in people with Parkinson Disease and Essential Tremor, run by KU Leuven at 1 site in Belgium.
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 16 inclusion and 4 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: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stage 1: Therapeutic window = Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes). (time frame: Immediately after testing). The study lists 6 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 29 Apr 2022.