Back to resultsTMS Treatment in Parkinson's Disease With Pain. (TMSPDP)
Primary Purpose
Transcranial Magnetic Stimulation, Parkinson Disease, Pain
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring TMS, Parkinson's disease, pain
Eligibility Criteria
Inclusion Criteria:
- Patients with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria;
- Age ≥ 18 Aged ≤ 80 years old;
- PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant.
- After treatment with anti-Parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for ≥ 14 days, and the dosage is maintained during the treatment;
- Ability to follow research plans and visit plans.
Exclusion Criteria:
- Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome.
- PD patients with persistent head tremors.
- Dementia, simple intelligent state check (mmse) ≤ 24 points.
- Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery.
6. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
Sites / Locations
- The Neurology Department of Xuanwu Hospital,Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Pain in PD Arm one
Pain in PD Arm two
Arm Description
This arm will receive a total 5 sessions of TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.
This arm will receive a total 5 sessions of sham-TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.
Outcomes
Primary Outcome Measures
Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.
To quantify changes of the severity of pain.
Secondary Outcome Measures
Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.
To quantify changes of the severity of the motor symptoms of Parkinson's Disease.
Full Information
NCT ID
NCT04048265
First Posted
August 6, 2019
Last Updated
April 13, 2020
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT04048265
Brief Title
TMS Treatment in Parkinson's Disease With Pain.
Acronym
TMSPDP
Official Title
Study of rTMS in the Treatment of Early/Moderate Parkinson's Disease With Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
November 29, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
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
Data Monitoring Committee
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 48 patients who are suffering from pain and have PD. These patients would require an EEG before and after 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
Transcranial Magnetic Stimulation, Parkinson Disease, Pain
Keywords
TMS, Parkinson's disease, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain in PD Arm one
Arm Type
Experimental
Arm Description
This arm will receive a total 5 sessions of TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.
Arm Title
Pain in PD Arm two
Arm Type
Sham Comparator
Arm Description
This arm will receive a total 5 sessions of sham-TMS stimulation in a week. Pre and post intervention scales will be performed on week one, week 2 and week 4.
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
Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.
Description
To quantify changes of the severity of pain.
Time Frame
Pre-treatment, post-treatment 0, 4 weeks
Secondary Outcome Measure Information:
Title
Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.
Description
To quantify changes of the severity of the motor symptoms of Parkinson's Disease.
Time Frame
Pre-treatment, post-treatment 0, 4 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 with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria;
Age ≥ 18 Aged ≤ 80 years old;
PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant.
After treatment with anti-Parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for ≥ 14 days, and the dosage is maintained during the treatment;
Ability to follow research plans and visit plans.
Exclusion Criteria:
Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome.
PD patients with persistent head tremors.
Dementia, simple intelligent state check (mmse) ≤ 24 points.
Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery.
6. Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Biao Chen, MD,PHD
Organizational Affiliation
Xuanwu Hospital of Capital Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
The Neurology Department of Xuanwu Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
12. IPD Sharing Statement
Learn more about this trial
TMS Treatment in Parkinson's Disease With Pain.
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