Neuromodulation With Percutaneous Electrical Nerve Field Stimulation

Conditions

• Gastroparesis Like Symptoms

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Activated IB-Stim Device — DEVICE
  The electrode/needle arrays are placed according to the individual's arterial and cranial nerve anatomy. The exact location of the placement may vary slightly from person to person but is determined by both knowledge of auricular neuro-anatomy and visualization of the neurovascular bundles by transillumination (NEURAXIS, Versailles, IN, USA). The points will be targeted by four-point electrical stimulation using the device after carefully disinfecting the ear. The small device will be positioned and secured behind the ear similar to a hearing aid, which may be covered by hair. Neurostimulation will be delivered below sensation threshold for 5 consecutive days. The device will be applied by a trained provider. A total of 4 weeks of neurostimulation will be performed
• Inactivated IB-Stim Device — DEVICE
  This control device will be identical in every way to the active device except it will lack the battery. The devices will be "made to order" when requested by the PI and will be shipped packaged as above. Both the subjects and the doctors placing the devices will be blinded, as the treatment and inactive devices will look identical with identical packaging and placement procedures.

Study Details

The IB-Stim is the first device to be approved by the Food and Drug Administration (FDA) for the treatment of functional abdominal pain in adolescents aged 11-18 with IBS. However, the efficacy of Percutaneous electrical nerve field stimulation (PENFS) in adults with gastroparesis like symptoms (GPLS) is not currently known. This study is a double-blind, randomized, sham-controlled pilot study evaluating the efficacy of PENFS using IB-Stim in adult patients with GPLS. A secondary aim will be to assess whether treatment with PENFS is associated with changes in autonomic function via heart rate variability.

Key Dates

Start date

Jan 8, 2026

Status verified

Mar 2026

Primary completion

Jun 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Active PENFS Device
  Participants in this arm have active PENFS device stimulation
• Sham Comparator: Control Arm
  Participants in this arm have inactive PENFS device

Primary Outcome Measure

Change in abdominal pain scores (on a 0-10 point rating scale, where 10 is the worst) from Baseline to Week 4 [ Time Frame: From Baseline through Week 4 ]

Locations (1)

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