CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
NIN +2 moredevice
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/NCT03060122
NCT03060122N/ACompleted

The Clinical Feasibility of Combining Cranial Electrotherapy Stimulation (CES Alpha-Stim) and Non-invasive Interactive Neurostimulation (InterX) for Optimized Rehabilitation Following Extremity Immobilization

Brooke Army Medical Center·interventional·Posted Feb 23, 2017·Updated Nov 25, 2019

In Brief

A clinical study evaluating NIN, Sham CES, and 1 other intervention for Neuropathic Pain. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This study will be aimed at assessing the feasibility of a dual-device treatment prior to a rehabilitation session for an orthopaedic injury requiring immobilization, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. The investigators will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and Inter-X treatment into a standard rehabilitation protocol to address risk factors associated with the development of neuropathic pain (i.e., pain, range of motion, and skin temperature) as well as its impact on reduced pain medication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartMar 1, 2018
Primary CompletionJul 31, 2019
Study CompletionAug 7, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.4 years ago

Interventions

NINdevice

The InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area.

Sham CESdevice

The sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level.

CESdevice

Cranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device.