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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03053752
• Other study ID #: CAAE: 14877213.8.0000.5208
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: February 10, 2017
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: February 2017
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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 gu (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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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