Parkinson DiseaseNCT03053752
Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
A study testing Transcutaneous Electric Nerve Stimulation in people with Parkinson Disease, run by Universidade Federal de Pernambuco.
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcutaneous Electric Nerve Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn \& Yahr (HY) scale
Who cannot join
- 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.
About this study
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.
- Conditions
- Parkinson Disease
- Being tested
- Transcutaneous Electric Nerve Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electric Nerve StimulationProcedure or surgery
Also called Tens
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electric Stimulation | Experimental | 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. Receives: Procedure: Transcutaneous Electric Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NADJA MARIA JORGE ASANO, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053752
- Sponsor's protocol ID
- CAAE: 14877213.8.0000.5208
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electric Nerve Stimulation in Sleep of Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03053752
- Acronym / sponsor ID
- CAAE: 14877213.8.0000.5208
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electric Stimulation | Experimental | Procedure: Transcutaneous Electric Nerve StimulationEight 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of idiopathic PD between stages 1 and 3 according to the original version of the Hoehn \& Yahr (HY) scale
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electric Nerve StimulationAlso: TensEight 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 or surgery | Transcutaneous Electric Stimulation |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electric Nerve Stimulation in people with Parkinson Disease, run by Universidade Federal de Pernambuco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scale for Parkinson's disease (PDSS) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2017; AzTrials last refreshed its copy on 8 Nov 2026.