Clinical trial NCT03350464: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Neuropathic Pain
Pain
Lead sponsor: Walton Centre NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Patients who have a diagnosis of Parkinson's Disease.
2. Medical treatment for the movement disorder to be optimized prior to the study.
3. Despite optimum medical therapy neuropathic pain is a major complaint for the patient:

   1. A minimum total score on the King's Pain Scale of 12 or
   2. A minimum subset domain score on Fluctuation-related Pain of 6 or
   3. A minimum subset domain score on Nocturnal pain of 5 or
   4. A minimum subset domain score on Radicular Pain of 3 or
4. No other cause for the pain is identified.
5. Age 18-80
6. Weekly average pain levels of 3/10 or more at the time of entry
7. The patient is capable of and willing to give informed consent for their participation.
8. 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:

1. Are suffering from pain not attributable from Parkinson's Disease
2. Are suffering from any neurological or psychiatric disease that could interfere with provision of reliable data (dementia, major depression, drug abuse, alcoholism)
3. Are suffering from a rapidly progressing malignant disease or other systemic disease that is likely to significantly interfere with their participation in the study
4. Are candidates or have been listed for surgery or other major medical intervention requiring hospitalisation and/or rehabilitation (e.g., hip replacement).
5. Have a history of seizures or epilepsy,
6. Require high doses of medication known to lower the threshold for seizures (e.g., amitriptyline \> 100mg/d,
7. Have cerebral space occupying lesion,
8. Have a history of severe head injury (associated with a suspicion of brain injury, e.g. resulting in unconsciousness for over 24 hrs)
9. Have metal located in head (e.g. shrapnel, surgical clips, fragments from welding),
10. Have a cochlear implant,
11. Have a cardiac pacemaker in situ,
12. Have a deep brain or vagal nerve stimulator in situ,
13. Are pregnant

Primary outcomes:
measure: No change in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III
timeFrame: 10 weeks
Secondary outcomes:
measure: 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
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: The Walton Centre NHS Foundation Trust
state: Mersey
Study officials:
References: