Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to see how much pain intensity is affected by high frequency spinal cord stimulation therapy in individuals with serious brachial plexus injury.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

NCT06494059

SCI - Spinal Cord Injury

RECRUITING NA

High Definition Neuromuscular Stimulation in Tetraplegia

NCT04075812

Spinal Cord Injury at C4-C6 Level

COMPLETED NA

Upper Extremity Training for Chronic Cervical Spinal Cord Injury

NCT04921592

Spinal Cord Injuries

RECRUITING NA

Stem Cell Therapy to Improve the Muscle Function of Patients With Partly Denervated Muscles of the Arm

NCT00755586

Brachial Plexus Injury

UNKNOWN PHASE1/PHASE2

The Efficacy of Motor Cortex Stimulation for Pain Control

NCT00462566

Neuropathic Pain Phantom Limb Pain Stump Pain +4 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This single-site prospective observational cohort study will include all adults (\> 18 years old) with brachial plexus avulsion injury who are candidates for high frequency (HF10) spinal cord stimulation (SCS). We plan to prospectively observe patients who undergo implantation of HF10 SCS for the indication of chronic neuropathic pain of the upper limb following brachial plexus avulsion injury.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brachial Plexus Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults with pain due to brachial plexus avulsion injury

Adult patients with history of brachial plexus avulsion injury referred for consideration of neuromodulation using high frequency neurostimulation will be considered.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 18 years old
* Neuropathic pain of the upper limb ≥ 3 months following brachial plexus avulsion injury.
* Patients must be planned to undergo implantation of high-frequency spinal cord stimulation for the treatment of chronic neuropathic pain due to brachial plexus avulsion injury.

Exclusion Criteria

* Pain that is non-neuropathic as defined by DN4 score \<4.
* Pregnant at the time of consideration for implant or planning to become pregnant during the study duration.
* Active substance use disorder of any kind.
* Active tobacco use.
* Use of moderate or high dose opioid medication (oral morphine equivalents \>100 mg daily).
* Active, untreated major psychiatric disorder that might interfere with subject's ability to participate.
* Involvement in active litigation related to injury.
* Patient has not undergone conservative medical management for at least 3 months (including physical and/or occupational therapy and at least one trial of neuropathic pain medication).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No