Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
1 other identifier
interventional
14
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started May 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 15, 2017
CompletedFebruary 15, 2017
February 1, 2017
1.3 years
February 8, 2017
February 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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).
8 weeks
Study Arms (1)
Transcutaneous Electric Stimulation
EXPERIMENTALEight 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn \& Yahr (HY) scale
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD
Study Record Dates
First Submitted
February 8, 2017
First Posted
February 15, 2017
Study Start
May 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 15, 2017
Record last verified: 2017-02