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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03053752
First Posted: February 15, 2017
Last Update Posted: February 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
NADJA MARIA JORGE ASANO, Universidade Federal de Pernambuco
  Purpose
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.

Condition Intervention
Parkinson Disease Procedure: Transcutaneous Electric Nerve Stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by NADJA MARIA JORGE ASANO, Universidade Federal de Pernambuco:

Primary Outcome Measures:
  • 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).


Enrollment: 14
Actual Study Start Date: May 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Tens

  Eligibility

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: NADJA MARIA JORGE ASANO, PHD, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03053752     History of Changes
Other Study ID Numbers: CAAE: 14877213.8.0000.5208
First Submitted: February 8, 2017
First Posted: February 15, 2017
Last Update Posted: February 15, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases