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Recruiting NCT06029075

tACS for Neuropathic Pain Management After SCI

No phase Interventional Neuropathic Pain Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: tACS Sham, tACS 10Hz, tACS 20Hz.
Who it may be relevant to
Registry conditions: Neuropathic Pain Management. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

Overview

The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for neuropathic pain management in people after spinal cord injury.

Interventions

  • Device tACS Sham
    Sham tACS will applied to the brain through the scalp for 20 minutes.
  • Device tACS 10Hz
    10Hz tACS will applied to the brain through the scalp for 20 minutes.
  • Device tACS 20Hz
    20Hz tACS will applied to the brain through the scalp for 20 minutes.

Primary outcome measures

  • Pain scale (visual analogue scale, VAS) measurement [Time frame: Change of VAS 5 minutes before and after the tACS intervention will be measured.]
  • Heart rate variability (HRV) measurement [Time frame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.]

Eligibility criteria

Inclusion/exclusion criteria for SCI subjects

Inclusion criteria: A patient who

  • has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
  • has chronic pain, >3 months;
  • is between 18 to 75 years of age;
  • is stable on oral pain medications at least two weeks. Patients are allowed to continue their pain medications, i.e., no change in pain medications.

NOTE: we plan to begin the study with the spinal cord injury (SCI) subject population as a cohort first, then expand to other subject populations

Exclusion criteria: Patients will be excluded if they

  • are currently adjusting oral pain medications for their neuropathic pain;
  • have pain, but not neuropathic, e.g., from inflammation at the incision wound of the residual limb or neuroma;
  • have a pacemaker metal implants or supplemental oxygen;
  • have amputation in their arm(s);
  • fail to have a motor contraction in the arm muscles with TMS;
  • are not able to follow commands, or to give consent;
  • have asthma or other pulmonary disease;
  • are not medically stable;
  • have preexisting psychiatric disorders;
  • alcohol or drug abuse.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The University of Texas Health Science Center — Houston

Identifiers

NCT: NCT06029075 · HSC-MS-22-0046 (Experiment 2)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗