CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Peripheral Nerve Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02928055
NCT02928055N/ACompleted
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Implanted PNS for Shoulder Pain in Stroke

MetroHealth Medical Center·interventional·Posted Oct 7, 2016·Updated Jun 18, 2021

In Brief

A clinical study evaluating Peripheral Nerve Stimulation for Stroke and Shoulder Pain. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The primary objective of this RCT is explore the mechanism for Hemiplegic Shoulder Pain (HSP) reduction due to treatment with peripheral nerve stimulation. We will explore the association of subject-specific clinical and demographic information and pain relief from PNS. We will explore the possible role of central sensitization mechanisms in perpetuating pain via measures of sensory and pain perception. Lastly, we will explore the dose-response association of muscle-contraction from PNS and pain reduction, completion of activities of daily living (ADLs), and improvement in quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke, Shoulder Pain
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Case Western Reserve University

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedOct 7, 2016
Enrollment StartOct 1, 2016
Primary CompletionAug 1, 2019
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.7 years ago

Interventions

Peripheral Nerve Stimulationdevice

The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.