Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders (INSHAPE_DBS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04725045 |
Recruitment Status :
Enrolling by invitation
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease Essential Tremor | Device: Boston Scientific: Study tool computer | Not Applicable |
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 (30 minutes and if safe, 1 week) in a larger number of patients.
In Parkinson's disease (PD) patients (after 30 minutes):
- MDS-UPDRS-III (Movement Disorders Society - Unified Parkinson's Disease Rating Scale, part III)
In essential tremor (ET) patients (after 30 minutes):
- FTM (Fahn Tolosa Marin Tremor Rating Scale)
In PD patients (after one week):
- MDS-UPDRS-III
- PDQ-39 (Parkinson's disease questionnaire - 39 items)
- NMSS (Non-motor Symptoms Scale)
In ET patients (after one week):
- FTM
- QUEST (Questionnaire for Quality of Life in Essential Tremor)
- MOCA (Montreal Cognitive Assessment)
Stage 3 will then focus on long-term evaluation (upto 2 years). The same tests are used as after the one-week testing.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomized, crossover, double-blinded design |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Double-blinded design |
Primary Purpose: | Supportive Care |
Official Title: | Investigating the Use of Complex Pulse Shapes for DBS in Movement Disorders |
Actual Study Start Date : | February 12, 2019 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | August 31, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard clinical pulse shape
Standard clinical pulse shape as used in clinical practice (cathodic stimulation).
|
Device: Boston Scientific: Study tool computer
compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape |
Experimental: Complex pulse shape
Complex pulse shape (i.e. biphasic pulse shape anode first, biphasic pulse shape cathode first, hyperpolarizing pre-pulse or depolarizing pre-pulse)
|
Device: Boston Scientific: Study tool computer
compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape |
- Therapeutic window [ Time Frame: 5 minutes ]Amplitude at which therapeutic benefit is obtained versus amplitude at which side-effects occur, both expressed in mA (milliamperes).
- 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 ]Follow-up of (S)AE related to the study upto 1 week after the experiment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for PD:
- 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.
Inclusion Criteria for ET:
- Patient is diagnosed with essential tremor by a Movement Disorder Specialist.
- Diagnosis since more than 3 years.
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725045
Belgium | |
KU Leuven | |
Leuven, Belgium, 3000 |
Principal Investigator: | Myles Mc Laughlin, Prof. Dr. | KU Leuven |
Responsible Party: | Myles Mc Laughlin, Clinical Professor, KU Leuven |
ClinicalTrials.gov Identifier: | NCT04725045 |
Other Study ID Numbers: |
S61020 |
First Posted: | January 26, 2021 Key Record Dates |
Last Update Posted: | January 26, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Parkinson Disease Essential Tremor Movement Disorders Parkinsonian Disorders Basal Ganglia Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases |