Clinical trial

Scrambler Therapy for Post-Stroke Pain

Name

IRB00323440

Description

The Investigators will enroll patients who have had a stroke and are experiencing post-stroke pain secondary to their infarct and disruption of the sensory system in a research study to compare the effectiveness of Scrambler Therapy to traditional pharmacologic therapies.

Trial arms

Trial start

2023-05-15

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Scrambler Therapy

Scrambler Therapy is a non-invasive neuromodulator treatment that focuses on relieving chronic pain through the sending of non-pain signals to the brain through the afferent pain sensory nerves. The signals given off by the scrambler therapy machine are intended to mimic neuronal action potentials through the synthesis of 16 unique waveforms that in combination forms "a patient specific cutaneous electrostimulation to reduce pain". These information packets are then carried by the afferent C-fibers, an established system that modulates the sensations received instead of blocking them. The modulated signals are received as "nonpainful" and endogenous by the central nervous system.

Arms:

Scrambler Therapy Group 5 sessions

Other names:

Calmare Therapy

Standard Medication Management

Medications such as: gabapentin, duloxetine and Lyrica are all FDA approved for treatment of neuropathic pain, particularly that caused by diabetes.

Arms:

Scrambler Therapy Group 10 sessions

Size

Primary endpoint

Reduction in post stroke pain

6 months

Eligibility criteria

Inclusion Criteria: * Men and women over the age of 18 with ischemic or hemorrhagic stroke seen on imaging and a positive finding for pain in the area(s) affected by their stroke location will be included. * The patients must be at least one month post-stroke but can otherwise enroll at any point. Exclusion Criteria: * Patients with TIA * Patients with no evidence of stroke on MRI * Patients with implantable devices such as pacemakers, defibrillators, spinal cord stimulators * Patients with history of myocardial infarction in the past 6 months * Patients with uncontrolled epilepsy * Patients with symptomatic brain metastases

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Scrambler Group and Non-scrambler group', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2023-12-27

1 organization

Organization

Johns Hopkins University