Parkinson DiseaseNCT03350464
Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
A study testing Repetitive Transcranial Magnetic Stimulation in people with Parkinson Disease and Neuropathic Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient basis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Neuropathic Pain, Pain
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2018to 11 Dec 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a diagnosis of Parkinson's Disease.
- Medical treatment for the movement disorder to be optimized prior to the study.
- Despite optimum medical therapy neuropathic pain is a major complaint for the patient:
- A minimum total score on the King's Pain Scale of 12 or
- A minimum subset domain score on Fluctuation-related Pain of 6 or
- A minimum subset domain score on Nocturnal pain of 5 or
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- A minimum subset domain score on Radicular Pain of 3 or
- No other cause for the pain is identified.
- Age 18-80
- Weekly average pain levels of 3/10 or more at the time of entry
- The patient is capable of and willing to give informed consent for their participation.
- The patient is capable of and willing to fill in a daily Pain diary during the study.
Who cannot join
- Patients will be excluded from the trial if they:
- Are suffering from pain not attributable from Parkinson's Disease
- Are suffering from any neurological or psychiatric disease that could interfere with provision of reliable data (dementia, major depression, drug abuse, alcoholism)
- Are suffering from a rapidly progressing malignant disease or other systemic disease that is likely to significantly interfere with their participation in the study
- Are candidates or have been listed for surgery or other major medical intervention requiring hospitalisation and/or rehabilitation (e.g., hip replacement).
- Have a history of seizures or epilepsy,
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- Require high doses of medication known to lower the threshold for seizures (e.g., amitriptyline > 100mg/d,
- Have cerebral space occupying lesion,
- Have a history of severe head injury (associated with a suspicion of brain injury, e.g. resulting in unconsciousness for over 24 hrs)
- Have metal located in head (e.g. shrapnel, surgical clips, fragments from welding),
- Have a cochlear implant,
- Have a cardiac pacemaker in situ,
- Have a deep brain or vagal nerve stimulator in situ,
- Are pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, Mersey, L97LJ
About this study
Official title: Open-label Pilot Study Using Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of pain.
The study intends to use this technique to treat such a disabling symptom in patients who suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in ten patients who are suffering from pain and have PD. These patients would initially require an MRI scan which allows us to map the brain and target the correct brain areas for the delivery of the stimulation. The stimulation would be performed over ten sessions and the patients would be assessed by a clinician using well recognized clinical tools.
It is anticipated that there will be a meaningful improvement in pain. It is also anticipated that TMS is a safe technique to use in patients with PD. The study will be used to help plan a future study that compares TMS with sham technique to prove whether TMS could be an option in the treatment of such a disabling condition.
- Conditions
- Parkinson Disease, Neuropathic Pain, Pain
- Being tested
- Repetitive Transcranial Magnetic Stimulation
- Medical subject headings
- Parkinson Disease, Neuralgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system
| Study group | Role | What they receive |
|---|---|---|
| Pain in PD Arm | Experimental | This arm will receive a total 10 sessions of TMS stimulation over 10 weeks. Pre and post intervention scales will be performed on week one and week 10. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No change in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III
UPDRS III is a clinical scale that measures the severity of the motor symptoms of Parkinson's Disease. No change is expected in the UPDRS III in the patients recruited from the start of the study to the end of the study.
Measured: 10 weeks
Secondary outcomes (1)
An improvement by a minimum of 30% in the pain caused by Parkinson's Disease as measured by the King's Parkinson's Disease Pain Scale
The King's PD Pain Scale measures the patient's pain caused by Parkinson's Disease. An improvement is expected in the pain caused by Parkinson's Disease of at least 30% on the Kings' PD Pain Scale.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start5 Apr 2018
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walton Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350464
- Sponsor's protocol ID
- PS024 RG237-18
- Status last verified
- Aug 2023
- First submitted
- 20 Oct 2017
- Last updated
- 24 Aug 2023
- Results posted
- No
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Pilot Study Using Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03350464
- Acronym / sponsor ID
- PS024 RG237-18
- Conditions
- Parkinson Disease, Neuropathic Pain, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Walton Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 22 Nov 2017 (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.
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient basis. It uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of pain.
The study intends to use this technique to treat such a disabling symptom in patients who suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in ten patients who are suffering from pain and have PD. These patients would initially require an MRI scan which allows us to map the brain and target the correct brain areas for the delivery of the stimulation. The stimulation would be performed over ten sessions and the patients would be assessed by a clinician using well recognized clinical tools.
It is anticipated that there will be a meaningful improvement in pain. It is also anticipated that TMS is a safe technique to use in patients with PD. The study will be used to help plan a future study that compares TMS with sham technique to prove whether TMS could be an option in the treatment of such a disabling condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pain in PD Arm | Experimental | Device: Repetitive Transcranial Magnetic StimulationThis arm will receive a total 10 sessions of TMS stimulation over 10 weeks. Pre and post intervention scales will be performed on week one and week 10. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who have a diagnosis of Parkinson's Disease.
- Medical treatment for the movement disorder to be optimized prior to the study.
- Despite optimum medical therapy neuropathic pain is a major complaint for the patient:
- No other cause for the pain is identified.
- Age 18-80
Key exclusion criteria (14 listed)
- Are suffering from pain not attributable from Parkinson's Disease
- Are suffering from any neurological or psychiatric disease that could interfere with provision of reliable data (dementia, major depression, drug abuse, alcoholism)
- Are suffering from a rapidly progressing malignant disease or other systemic disease that is likely to significantly interfere with their participation in the study
- Are candidates or have been listed for surgery or other major medical intervention requiring hospitalisation and/or rehabilitation (e.g., hip replacement).
- Have a history of seizures or epilepsy,
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationTranscranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system | Device | Pain in PD Arm |
Primary outcome
No change in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III
Time frame: 10 weeks
UPDRS III is a clinical scale that measures the severity of the motor symptoms of Parkinson's Disease. No change is expected in the UPDRS III in the patients recruited from the start of the study to the end of the study.
1 secondary outcome
An improvement by a minimum of 30% in the pain caused by Parkinson's Disease as measured by the King's Parkinson's Disease Pain Scale
Time frame: 10 weeks
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 24 Aug 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Parkinson Disease and Neuropathic Pain, run by Walton Centre NHS Foundation Trust at 1 site in United Kingdom.
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 12 inclusion and 14 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 24 Aug 2023. 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 United Kingdom. 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?
No change in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III (time frame: 10 weeks). 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 24 Aug 2023.