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NCT Number: NCT04677751

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

15 year–60 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 criteria

  • 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
  • Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization
  • Patient or caregiver able to maintain a seizure diary for duration of study

Exclusion criteria

  • Patient and /or caregiver is unable to sign informed consent to study
  • Patient has a bleeding disorder, pacemaker, or pregnant

Treatment and study plan

Acupuncture intervention

Device

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

Primary outcomes

  1. Percent change in number of disabling clinical seizures

    Time frame: Baseline,12 weeks post treatment

    This will be measured by self reporting journals

  2. Changes in seizure severity

    Time frame: Baseline,12 weeks post treatment

    This will be measured by self reporting journals

Secondary outcomes

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

    Time frame: Baseline,12 weeks post treatment

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

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

    Time frame: Baseline,12 weeks post treatment

    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).

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

    Time frame: Baseline,12 weeks post treatment

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

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

    Time frame: Baseline

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

    Time frame: end of 1 month

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

    Time frame: end of 2 months

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

    Time frame: end of 3 months

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

    Time frame: 1 month after last treatment

Study contacts

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

Ardonia N Tousant

CONTACT

[email protected]

(713) 500-5482

Olga Rodziyevska, MS,PA-C

CONTACT

[email protected]

(713) 500-5482

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 21, 2020
Registry last updated
Oct 1, 2024

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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