Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous Electric Nerve Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn & Yahr (HY) scale
Exclusion Criteria:
- Patients with Mini Mental State Examination (MMSE) lower than 18 points, with other associated neurological diseases and on medication for depression, anxiety, psychosis and sleep inducers.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcutaneous Electric Stimulation
Arm Description
Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.
Outcomes
Primary Outcome Measures
Scale for Parkinson's disease (PDSS)
A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never).
Secondary Outcome Measures
Full Information
NCT ID
NCT03053752
First Posted
February 8, 2017
Last Updated
February 10, 2017
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03053752
Brief Title
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Official Title
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sleep disorders are among the non-motor signs more common in Parkinson's disease (PD). This case series evaluated the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on acupoints in the self-assessment of sleep in 14 PD patients classified between stages 1 and 3 of Hoehn and Yahr original (HY). Patients were assessed using the Sleep Scale for Parkinson's Disease (PDSS) and subjected to treatment with eight TENS sessions on acupoints, with the current Burst. We used the paired sample t-test, considering p ≤ 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous Electric Stimulation
Arm Type
Experimental
Arm Description
Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.
Intervention Type
Procedure
Intervention Name(s)
Transcutaneous Electric Nerve Stimulation
Other Intervention Name(s)
Tens
Intervention Description
Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.
Primary Outcome Measure Information:
Title
Scale for Parkinson's disease (PDSS)
Description
A self-administered scale designed to assess nighttime sleep problems, sleep disorders and excessive daytime sleep. Consists of 15 items represented by a ruler (10 cm) where the patient indicates the frequency of the symptom from 0 (always)- 10 (never).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn & Yahr (HY) scale
Exclusion Criteria:
Patients with Mini Mental State Examination (MMSE) lower than 18 points, with other associated neurological diseases and on medication for depression, anxiety, psychosis and sleep inducers.
12. IPD Sharing Statement
Learn more about this trial
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
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