Parkinson's DiseaseNCT02610257
Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease
A study testing Mechanical stimulus (vibration) applied on the forearm in people with Parkinson's Disease and Somatosensory Disorders, run by KU Leuven at 1 site in Belgium.
Trial summary
Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism underlying these phenomena is still an open debate. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Somatosensory Disorders
- What is being tested?
- Mechanical stimulus (vibration) applied on the forearm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Jul 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PD patients (N=30):
- Diagnosis of PD based on the UK PD brain bank criteria
- Hoehn \& Yahr stage II-III (ON-medication)
Who cannot join
- Cognitive dysfunction Score on the Mini Mental State Examination (MMSE) < 23/30
- Medication change in the past 1 month
- Other neurological disorders
- Vestibular disorder
- Uncontrolled diabetes
- Cutaneous diseases
- Left-handedness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease With and Without Freezing of Gait
Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism underlying these phenomena is still an open debate. Apart from the motor correlates, cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive system) may underlie these motor blocks. The current study aims to unravel whether the proprioceptive system is involved by manipulating task-relevant or non-relevant proprioceptive stimuli.
Hence, the main aims of this study are:
Read more
(i) to assess the somatosensory function in people with PD that experience freezing of gait FOG and (ii) to investigate the effects of manipulating both proprioception and attentional resources on FOUL severity.
Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly, PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous sensory function and kinesthetic ability will be assessed by means of standardized user-friendly methods and precise repositioning measures using the VICON motion analysis. Additionally, participants will perform a newly developed task that can successfully elicit FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The task will be performed without and with the use of muscle vibration (a well-known method to stimulate the proprioceptive system). The investigators will manipulate both the timing of vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation; and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present with worse somatosensory function than those who do not experience motor blocks (especially in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently of the region stimulated. In contrast, it is also expected that when vibration is applied in a non-relevant way and it may act as a distractor, FOUL duration will increase. This study will thus be able to distinguish between the contribution of attentional and proprioceptive resources to the mechanism of motor blocks in PD.
- Conditions
- Parkinson's Disease, Somatosensory Disorders
- Being tested
- Mechanical stimulus (vibration) applied on the forearm
- Keywords
- Parkinson's disease, Freezing of gait, Motor blocks, Somatosensory, Proprioception, Muscle vibration, Handwriting
- Medical subject headings
- Parkinson Disease, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical stimulus (vibration) applied on the forearmDevice
Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.
Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports.
| Study group | Role | What they receive |
|---|---|---|
| Vibration Relevant | Active comparator | Vibration applied on the muscle belly after 'motor block' onset Receives: Device: Mechanical stimulus (vibration) applied on the forearm |
| Neutral Vibration Relevant | Active comparator | Vibration applied on a bony mark after 'motor block' onset Receives: Device: Mechanical stimulus (vibration) applied on the forearm |
| Neutral Vibration Non-Relevant | Active comparator | Vibration applied on a bony mark before 'motor block' onset Receives: Device: Mechanical stimulus (vibration) applied on the forearm |
| Vibration Non-Relevant | Active comparator | Vibration applied on the muscle belly after 'motor block' onset Receives: Device: Mechanical stimulus (vibration) applied on the forearm |
| No Vibration | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in upper limb motor blocks duration
Measured: 30 min
Joint Position Sense
Participants will be comfortably seated, while both forearms rest on a table with hands facing down. Then, the right arm should slowly and actively be moved to a certain target angle indicated by the test leader. This target angle should be memorized while holding their arm at this position for 4s, after which participants slowly return their arm to the starting position. After 3s, participants will be asked to actively reproduce the previous target position with the same limb. All trials will be conducted while participants maintain their eyes closed and with their elbow off the table surface. The limb position will be recorded by using 7 MX-T20 optoelectronic cameras (Vicon, Oxford Metrics, UK). For this 3D movement analysis, each participant will be instrumented with 10 spherical reflective markers positioned on participants' right shoulder, arm, elbow, forearm and hand.
Measured: 15 min
Perceptual Threshold of Touch
For this test a dual channel nerve stimulator (TENS) will be used (CEFAR PRIMO PRO - CEFAR Medical AB®). Participants will be seated in a standardized and comfortable way, allowing them to observe the entire procedure. Two individual electrodes (3cm of diameter) will be placed on bulb of the index finger (anode) and on the tenar region of the same limb (cathode). A constant current of 40Hz with single square pulses with 80μs of duration will be used. The current amplitude will be increased in steps of 0.5mA at every 2 seconds. The participant will be instructed to say "now" when they feel a slight tingling sensation. Three trials will be used for both hands. The Perceptual Threshold of Touch will be considered as the average of the three trials. It is expected that subjects will feel a slight itching and painless sensation. To avoid any discomfort, the test will be interrupted whenever an involuntary movement is seen, since the Motor Threshold always precedes the Pain Threshold.
Measured: 15 min
Secondary outcomes (2)
Writing amplitude assessed by a tablet
The paradigm consists of performing a task on a 16.5cm length tablet (Fujitsu Componentes Europe®) .The device is powered by a regular laptop. To maximize participants' comfort the tablet screen is squared. The task consists of a 'freezing-provoking task'. This 'freezing-provoking' task has already been tested in people with PD in a current writing study at the Neuromotor Research Group . This task has been shown to be highly successful to elicit motor blocks in the upper limbs in PD patients (data submitted for publication). Each trial will last 30 seconds and as much trials as needed will be provided before the data collection to ensure participants have learned the task.
Measured: 30 min
Somatosensory Function
Assessed by the Erasmus Notthingham Sensory Assessment (EmNSA)
Measured: 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Alice Nieuwboer, KU Leuven
- Investigators
- Alice Nieuwboer, Professor, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610257
- Sponsor's protocol ID
- S58674
- Status last verified
- Aug 2017
- First submitted
- 17 Nov 2015
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Somatosensory Dysfunction as the Underlying Mechanism of Upper Limbs Motor Blocks in People With Parkinson's Disease With and Without Freezing of Gait
- ClinicalTrials.gov ID
- NCT02610257
- Acronym / sponsor ID
- S58674
- Conditions
- Parkinson's Disease, Somatosensory Disorders
- Keywords
- Parkinson's disease, Freezing of gait, Motor blocks, Somatosensory, Proprioception, Muscle vibration, Handwriting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
Motor blocks during gait and upper limb movements (FOULs) are a disabling and common motor impairment in mild to severe stages of Parkinson's disease (PD). However, the main mechanism underlying these phenomena is still an open debate. Apart from the motor correlates, cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive system) may underlie these motor blocks. The current study aims to unravel whether the proprioceptive system is involved by manipulating task-relevant or non-relevant proprioceptive stimuli.
Hence, the main aims of this study are:
(i) to assess the somatosensory function in people with PD that experience freezing of gait FOG and (ii) to investigate the effects of manipulating both proprioception and attentional resources on FOUL severity.
Forty-five people will be assigned to three age-matched groups (N=15 each): healthy elderly, PD patients that experience FOG (FOG+) and PD patients that do not experience FOG. Cutaneous sensory function and kinesthetic ability will be assessed by means of standardized user-friendly methods and precise repositioning measures using the VICON motion analysis. Additionally, participants will perform a newly developed task that can successfully elicit FOULs (a handwriting freezing-provoking task) on a custom tablet (Heremans et al 2015). The task will be performed without and with the use of muscle vibration (a well-known method to stimulate the proprioceptive system). The investigators will manipulate both the timing of vibration (relevant - after FOUL onset; or non-relevant: before FOUL onset) and the region of stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation; and on a non-neutral spot: on the forearm muscles). It is believed that FOG+ will present with worse somatosensory function than those who do not experience motor blocks (especially in the proprioceptive system). Additionally, the Investigators expect a reduction in FOUL severity (e.g. FOUL duration) when vibration is applied in a task-relevant way, independently of the region stimulated. In contrast, it is also expected that when vibration is applied in a non-relevant way and it may act as a distractor, FOUL duration will increase. This study will thus be able to distinguish between the contribution of attentional and proprioceptive resources to the mechanism of motor blocks in PD.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vibration Relevant | Active comparator | Device: Mechanical stimulus (vibration) applied on the forearmVibration applied on the muscle belly after 'motor block' onset |
| Neutral Vibration Relevant | Active comparator | Device: Mechanical stimulus (vibration) applied on the forearmVibration applied on a bony mark after 'motor block' onset |
| Neutral Vibration Non-Relevant | Active comparator | Device: Mechanical stimulus (vibration) applied on the forearmVibration applied on a bony mark before 'motor block' onset |
| Vibration Non-Relevant | Active comparator | Device: Mechanical stimulus (vibration) applied on the forearmVibration applied on the muscle belly after 'motor block' onset |
| No Vibration | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PD patients (N=30):
- Diagnosis of PD based on the UK PD brain bank criteria
- Hoehn \& Yahr stage II-III (ON-medication)
Key exclusion criteria (7 listed)
- Cognitive dysfunction Score on the Mini Mental State Examination (MMSE) < 23/30
- Medication change in the past 1 month
- Other neurological disorders
- Vestibular disorder
- Uncontrolled diabetes
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 |
|---|---|---|
| Mechanical stimulus (vibration) applied on the forearmLocal vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name. Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports. | Device | Neutral Vibration Non-Relevant, Neutral Vibration Relevant, Vibration Non-Relevant, Vibration Relevant |
Primary outcome
Change in upper limb motor blocks duration
Time frame: 30 min
Joint Position Sense
Time frame: 15 min
Participants will be comfortably seated, while both forearms rest on a table with hands facing down. Then, the right arm should slowly and actively be moved to a certain target angle indicated by the test leader. This target angle should be memorized while holding their arm at this position for 4s, after which participants slowly return their arm to the starting position. After 3s, participants will be asked to actively reproduce the previous target position with the same limb. All trials will be conducted while participants maintain their eyes closed and with their elbow off the table surface. The limb position will be recorded by using 7 MX-T20 optoelectronic cameras (Vicon, Oxford Metrics, UK). For this 3D movement analysis, each participant will be instrumented with 10 spherical reflective markers positioned on participants' right shoulder, arm, elbow, forearm and hand.
Perceptual Threshold of Touch
Time frame: 15 min
For this test a dual channel nerve stimulator (TENS) will be used (CEFAR PRIMO PRO - CEFAR Medical AB®). Participants will be seated in a standardized and comfortable way, allowing them to observe the entire procedure. Two individual electrodes (3cm of diameter) will be placed on bulb of the index finger (anode) and on the tenar region of the same limb (cathode). A constant current of 40Hz with single square pulses with 80μs of duration will be used. The current amplitude will be increased in steps of 0.5mA at every 2 seconds. The participant will be instructed to say "now" when they feel a slight tingling sensation. Three trials will be used for both hands. The Perceptual Threshold of Touch will be considered as the average of the three trials. It is expected that subjects will feel a slight itching and painless sensation. To avoid any discomfort, the test will be interrupted whenever an involuntary movement is seen, since the Motor Threshold always precedes the Pain Threshold.
2 secondary outcomes
Writing amplitude assessed by a tablet
Time frame: 30 min
Somatosensory Function
Time frame: 30 min
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 8 Aug 2017.
- Related InfoLink provided by the sponsor.
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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.
Alice Nieuwboer, Professor 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 Mechanical stimulus (vibration) applied on the forearm in people with Parkinson's Disease and Somatosensory Disorders, 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 3 inclusion and 7 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 8 Aug 2017. 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?
Change in upper limb motor blocks duration (time frame: 30 min). 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 8 Aug 2017.