tACS for Neuropathic Pain Management After SCI

The University of Texas System (UT)

Status: Begins enrollment in 3 months

Conditions: Neuropathic Pain Management

Treatments: Device: tACS 20Hz; Device: tACS 10Hz; Device: tACS Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06029075

HSC-MS-22-0046 (Experiment 2)

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion/exclusion criteria for SCI subjects

Inclusion criteria: A patient who

1. has neuropathic pain after traumatic spinal cord injury or amputation or brain injury;
2. has chronic pain, >3 months;
3. is between 18 to 75 years of age;
4. 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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 3 patient groups

"tACS Sham, tACS 10Hz, tACS 20Hz" experimental order

Experimental group

Description:

1. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

Treatment:

Device: tACS 10Hz

Device: tACS Sham

Device: tACS 20Hz

"HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental order

Experimental group

Description:

1. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 2. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

Treatment:

Device: tACS 10Hz

Device: tACS Sham

Device: tACS 20Hz

"HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental order

Experimental group

Description:

1. tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns. 2. tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns. 3. tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

Treatment:

Device: tACS 10Hz

Device: tACS Sham

Device: tACS 20Hz