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Mindfulness Meditation for Spinal Cord Injury

N/A
Waitlist Available
Led By Chelsea Ratcliff, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether a six-week mindfulness meditation training intervention can help people with spinal cord injuries and chronic pain, and if data collection procedures are feasible.

Who is the study for?
This trial is for people with spinal cord injury (SCI) who have had it for at least 6 months and suffer from chronic pain, rating their pain intensity 4 or higher on a scale of 10. Participants must understand English well enough to consent and complete surveys. They can't join if they lack daily internet access, have significant cognitive impairments, visual/hearing issues preventing app use, practice meditation frequently, or can't provide an email.
What is being tested?
The study tests the effectiveness of a mindfulness meditation training program delivered through an app over six weeks against health education as a control group in individuals with SCI experiencing chronic pain. The goal is to see how feasible and acceptable this intervention is and how well data collection works.
What are the potential side effects?
Since the interventions involve mindfulness meditation and health education rather than medical treatments or drugs, there are no direct physical side effects expected. However, participants may experience emotional discomfort when confronting painful experiences during meditation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability as assessed by the patient-reported program evaluation questionnaire scale
Feasibility as assessed by the number of participants that complete all visits
Secondary study objectives
Feasibility of collecting fatigue as assessed by the PROMIS Fatigue- Short Form 4a
Feasibility of collecting patient reported outcomes of anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire
Feasibility of collecting patient reported outcomes of brief pain as assessed by the Brief Pain Catastrophizing Scale (Brief PCS)
+8 more

Side effects data

From 2023 Phase 1 & 2 trial • 43 Patients • NCT05168735
100%
dissociative symptoms
67%
dizziness
43%
dry mouth
33%
decreased energy
33%
increased appetite
29%
nausea
24%
headache
14%
restlessness
10%
palpitations
10%
difficulty sleeping: too little
5%
anxiety
5%
diarrhea
5%
emotional indifference
5%
tremors
5%
difficulty sleeping: too much
5%
sweating
5%
trouble achieving orgasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous Ketamine + Academic Exercises
Intravenous Ketamine + Mindfulness Exercises

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mindfulness meditation(MM)Experimental Treatment1 Intervention
Group II: Health EducationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Sam Houston State UniversityOTHER
5 Previous Clinical Trials
1,100 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,992 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
862 Previous Clinical Trials
674,037 Total Patients Enrolled
TIRR Memorial HermannOTHER
15 Previous Clinical Trials
4,710 Total Patients Enrolled
Chelsea Ratcliff, PhDPrincipal InvestigatorSam Houston State University
Radha Korupolu, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

Mindfulness Meditation Training Clinical Trial Eligibility Overview. Trial Name: NCT05556057 — N/A
Spinal Cord Injury Research Study Groups: mindfulness meditation(MM), Health Education
Spinal Cord Injury Clinical Trial 2023: Mindfulness Meditation Training Highlights & Side Effects. Trial Name: NCT05556057 — N/A
Mindfulness Meditation Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556057 — N/A
~21 spots leftby Dec 2025
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