Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients With Acupuncture Treatment

ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-60
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient implanted with the RNS system

Patient can undergo 12 weeks of acupuncture

Patient is able remain on stable medications for 12 weeks

Patient is able to remain on stable Detection and Stimulation settings for 12 weeks

Disqualifiers

Patient and /or caregiver is unable to sign informed consent to study

Patient has a bleeding disorder, pacemaker, or pregnant

Trial design

Design model

Single group

Treatments tested in this trial

  • Acupuncture intervention

    Device

    Participants will undergo 12 weeks of acupuncture therapy. There will be one 40 minute-1 hour. session per week.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in number of disabling clinical seizures

This will be measured by self reporting journals

Time frame
Baseline,12 weeks post treatment
2

Changes in seizure severity

This will be measured by self reporting journals

Time frame
Baseline,12 weeks post treatment

Secondary outcomes

1

Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire

This is a 10 item questionnaire. Score ranges from 1-6,a higher number indicating a worse outcome.

Time frame
Baseline,12 weeks post treatment
2

Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)

PHQ-9 score can range from 0 to 27,each of the 9 items can be scored from 0 (not at all) to 3 (nearly every day).

Time frame
Baseline,12 weeks post treatment
3

Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale

This is a 7 item questionnaire. Each question is scored form 0(not at alll) to 3(nearly every day)

Time frame
Baseline,12 weeks post treatment
4

Average number of detections of seizures per-day (as stored by the RNS System)

Time frame
Baseline

Other outcomes

Sponsors and contacts

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