tACS for Neuropathic Pain Management After SCI
ConditionNeuropathic Pain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe University of Texas Health Science Center, Houston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
tACS Sham
DeviceSham tACS will applied to the brain through the scalp for 20 minutes.
tACS 10Hz
Device10Hz tACS will applied to the brain through the scalp for 20 minutes.
tACS 20Hz
Device20Hz tACS will applied to the brain through the scalp for 20 minutes.
Treatment groups
14 Participants
are divided into 3 treatment groupsGroup A: "tACS Sham, tACS 10Hz, tACS 20Hz" experimental orderExperimental treatment 3 interventions
Group B: "HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham" experimental orderExperimental treatment 3 interventions
Group C: "HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham" experimental orderExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pain scale (visual analogue scale, VAS) measurement
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."
Time frame
Change of VAS 5 minutes before and after the tACS intervention will be measured.2
Heart rate variability (HRV) measurement
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
Time frame
Change of HRV 10-15 minutes before and after the tACS intervention will be measured.Sponsors and contacts
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Source ClinicalTrials.gov