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Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disase

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ClinicalTrials.gov Identifier: NCT04165278
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nanjing First Hospital, Nanjing Medical University

Brief Summary:

The seasonal variation of motor and non-motor symptoms of Parkinson's disease (PD) has been receiving attention all the time. Two potential elements (temperature and sunlight) may explains how the seasonal variation could affect PD.

In clinical practice, part of PD patients from Jiangsu province complained that the motor symptoms of PD in winter (low temperature, less sunlight) were more severe than in summer. Seasonal variation in temperature may affect seasonal changes in the severity of PD. An investigation of hallucinations involving 51 PD patients reported no evidence of seasonal variations in clinical symptoms. However, the non-motor symptoms (NMS) in PD fluctuated throughout the year, with winter months being more severe than summer month s in a recent Cross - sectional retrospective study on 372 consecutive PD patients. Moreover, a study of 546 PD patients indicated no seasonal fluctuation in motor symptom severity, when measured with the Unified Parkinson's disease Rating Scale (UPDRS). We considered that seasonal fluctuations of motor symptoms of PD may be related to changes in temperature and sunlight, but light therapy has made some progress in the treatment of PD. Therefore, we began to ask these PD patients who were affected by temperature changes whether their motor symptoms were affected by hyperthermic baths.

In clinical practice, PD patients who complained that motor symptoms were more severe in winter felt the improvement of motor symptoms after HTB. Based on the current situation, we will conduct HTB study to further evaluate whether temperature is an important factor affecting the motor symptoms of PD patients, and the feasibility and effectiveness of simple HTB to improve the motor symptoms of PD.


Condition or disease Intervention/treatment Phase
Parkinson Disease Other: hyperthermic baths Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disase
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : September 27, 2019
Actual Study Completion Date : October 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: After hyperthermic baths
On the first, third and fifth day of the first week, each subject took the HTB at the same time. They would receive subjective measures before and after HTB.
Other: hyperthermic baths
Taking hyperthermic baths




Primary Outcome Measures :
  1. the Movement Disorder Society - United Parkinson's Disease Rating Scale (MDS-UPDRS) part III motor examination total scores Rating Scale [ Time Frame: 3 week ]
    score declined

  2. the modified Webster Symptoms Score [ Time Frame: 3 week ]
    score declined



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) ≥ 18 years of age;2) diagnosis of IPD based on the Movement Disorder Society (MDS) clinical diagnostic criteria for Parkinson's Disease;3) felt subjectively that motor symptoms of PD were affected by seasonal temperature and improved after HTB;4) there was no change in the patient's PD medication regimen during the study;5) no cognitive dysfunction, simple mental state scale (MMSE) score greater than the lower limit of normal (17 points for illiteracy, 20 points for primary school, 22 points for middle school and 23 points for university);Scores on the Montreal cognitive assessment scale (MoCA scale) were higher than 26 points (including 26 points), and those with less than 12 years of education (including 12 years) were added one point, with a maximum score of 30 points;6) voluntarily sign the informed consent

Exclusion Criteria:

1) secondary Parkinson's disease or Parkinson's superimposed syndrome;2) Had speech disorder, articulation disorder or deafness and son on;3) patients who cannot tolerate hyperthermic baths;4) patients with serious cardiovascular and cerebrovascular diseases, pulmonary insufficiency, liver and kidney insufficiency, tumor and other chronic wasting disease;s5) people with mental disorders;6) failed to cooperate with the study requirements and having poor compliance;7) the researchers do not consider the subjects of the clinical trial suitable for other reasons


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04165278


Locations
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China, Jiangsu
Yingdong Zhang
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
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Study Director: Yingdong Zhang, PhD Nanjing Medical University

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Responsible Party: Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT04165278     History of Changes
Other Study ID Numbers: KY20190926-05
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we'll share our study design and the study results with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: the data will become available 12 months after the study finished for 1 year
Access Criteria: clinical doctors

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanjing First Hospital, Nanjing Medical University:
Parkinson's disease, temperature, hyperthermic baths
Additional relevant MeSH terms:
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Parkinson Disease
Fever
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Body Temperature Changes
Signs and Symptoms