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NCT Number: NCT06029075

tACS for Neuropathic Pain Management After SCI

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tACS Sham

Device

Sham tACS will applied to the brain through the scalp for 20 minutes.

tACS 10Hz

Device

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

tACS 20Hz

Device

20Hz tACS will applied to the brain through the scalp for 20 minutes.

Primary outcomes

  1. Pain scale (visual analogue scale, VAS) measurement

    Time frame: Change of VAS 5 minutes before and after the tACS intervention will be measured.

    The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  2. Heart rate variability (HRV) measurement

    Time frame: Change of HRV 10-15 minutes before and after the tACS intervention will be measured.

    Heart rate variability (HRV) is the fluctuation in the time intervals between adjacent heartbeats (1). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system (ANS) processes. HRV will be used as a surrogate assessment for autonomic nerve system

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Li, MD, Ph.D

CONTACT

[email protected]

(713) 797-7125

Shengai Li, MS

CONTACT

[email protected]

713-797-7561

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Sep 8, 2023
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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