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Completed

NCT Number: NCT04048265

TMS Treatment in Parkinson's Disease With Pain.

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.

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Key information

Conditions

Transcranial Magnetic Stimulation Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pain Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Neurology Department of Xuanwu Hospital,Capital Medical University

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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 outcomes

  1. Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.

    Time frame: Pre-treatment, post-treatment 0, 4 weeks

    To quantify changes of the severity of pain.

Secondary outcomes

  1. Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.

    Time frame: Pre-treatment, post-treatment 0, 4 weeks

    To quantify changes of the severity of the motor symptoms of Parkinson's Disease.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Study of rTMS in the Treatment of Early/Moderate Parkinson's Disease With Pain.

Acronym: TMSPDP

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Aug 7, 2019
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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