Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease

February 10, 2017 updated by: NADJA MARIA JORGE ASANO, Universidade Federal de Pernambuco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Electric Stimulation
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.
Procedure: Transcutaneous Electric Nerve Stimulation
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.
Other Names:
  • Tens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale for Parkinson's disease (PDSS)
Time Frame: 8 weeks
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).
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Pernambuco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 10, 2017

First Posted (Actual)

February 15, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2017

Last Update Submitted That Met QC Criteria

February 10, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 14877213.8.0000.5208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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