Back to resultsRepetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
Primary Purpose
Parkinson Disease, Neuropathic Pain, Pain
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
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,
- 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
Sites / Locations
- The Walton Centre NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain in PD Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03350464
First Posted
October 20, 2017
Last Updated
August 22, 2023
Sponsor
Walton Centre NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03350464
Brief Title
Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
Official Title
Open-label Pilot Study Using Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2018 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Walton Centre NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Neuropathic Pain, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain in PD Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
No change in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III
Description
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.
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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,
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
Facility Information:
Facility Name
The Walton Centre NHS Foundation Trust
City
Liverpool
State/Province
Mersey
ZIP/Postal Code
L97LJ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation as a Treatment for Pain in Parkinson's Disease
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