Novel Stimulation Patterns to Improve the Effectiveness of Spinal Cord Stimulation

Part of paid clinical trials in Houston, Texas.

Sponsor
Ashwin Viswanathan
Study ID
NCT05968664
Status
Recruiting
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Conditions

  • Chronic Pain
  • Neuropathic Pain
  • Pain, Neuropathic

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spinal Cord Stimulator — DEVICE
    Spinal Cord Stimulator modified to deliver Time Variant Pulse (TVP) stimulation.
  • Spinal Cord Stimulator — DEVICE
    Spinal Cord Stimulator to deliver standard of care Time Invariant Pulse (TIP) stimulation.

Study Details

The goal of this study is to compare pain outcomes achieved by spinal cord stimulation (SCS) using time varying stimulation patterns with pain outcomes achieved by current standard of care SCS.

Key Dates

Start date
Aug 1, 2024
Status verified
Jun 2024
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
43 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Time Invariant Pulse(TIP) Stimulation
    The control arm for this study will be the Time Invariant Pulse stimulation which is used in standard of care Spinal Cord Stimulation therapy. TIP tonic stimulation is delivered with fixed amplitude, pulse width, and frequency parameters.
  • Experimental: Time Variant Pulse (TVP) Stimulation
    The time variant pulse (TVP) stimulation will serve as the experimental arm for this study. There are two ways of delivering TVP stimulation to the spinal cord. TVP stimulation can either vary in intensity or it can vary rate, referred to as intensity-modulated TVP or rate-modulated TVP, respectively.

Primary Outcome Measure

Change in Patient responder rate [ Time Frame: Patient responder rate will be measured from the baseline and during three experimental stimulation periods which are 8±3 weeks each. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Aswhin Viswanathan, MD

Find similar trials in Houston, TX

By research site
Baylor College of Medicine· Houston, TX

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