Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT04721717

Conditions

Spinal Cord Injuries

Multiple Sclerosis

Transverse Myelitis

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The UAB Institute for Arts In Medicine (AIM) is currently implementing an expressive emotional writing pilot project for adults with paralysis caused by neurological conditions such as traumatic head or spinal cord injury.

Conditions

Spinal Cord Injuries

Multiple Sclerosis

Transverse Myelitis

Amyotrophic Lateral Sclerosis

Study ID

NCT04721717

Start date

Sep 1, 2020

Status verified date

Aug, 2025

Completion date

Mar 28, 2027

Anticipated

Primary completion date

Mar 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Age 18 or older with paralysis living in the community
2. limb paralysis resulting from a traumatic event/accident or neurological disease (e.g., spinal cord injury, head injury, stroke, multiple sclerosis, Transverse myelitis, poliomyelitis, peripheral neuropathy, Parkinson's disease, ALS, botulism, and Guillain-Barré syndrome etc) happened after childhood
3. a non-traumatic spinal cord injury may be caused by arthritis, cancer, inflammation, infections or disk degeneration of the spine
4. caregivers of people with amyotrophic lateral sclerosis
5. able to communicate verbally or through writing

Exclusion Criteria:

1. known maladaptive behavioral patterns, exhibition of overt psychotic symptoms (e.g., presence of hallucinations, delusions, or thought disorders)
2. congenital (e.g., spinal bifida, cerebral palsy)

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

People with SCI

People with paraplegia and quadriplegia People with multiple sclerosis People with transverse myelitis Caregivers of people with amyotrophic lateral sclerosis (ALS)

Primary outcome measure

  • The Grief and Loss Scale [ Time Frame: 11 Weeks ]
  • Emotional Distress - Depression [ Time Frame: 11 Weeks ]
  • Perceived Stress Scale [ Time Frame: 11 Weeks ]
  • Impact of Events Scale [ Time Frame: 11 Weeks ]
  • Meaning and Purpose [ Time Frame: 11 Weeks ]
  • Self-Efficacy for Managing Chronic Conditions - Managing Emotions [ Time Frame: 11 Weeks ]
  • Sleep Disturbance [ Time Frame: 11 Weeks ]
  • Sleep Impact [ Time Frame: 11 Weeks ]
  • Ability to Participate in Social Roles and Activities [ Time Frame: 11 Weeks ]
  • Satisfaction with Social Roles and Activities [ Time Frame: 11 Weeks ]
  • Connor-Davidson Resilience Scale [ Time Frame: 11 weeks ]

Central Contacts and Locations

Locations

354 School of Health Professions Building

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Principal Investigator:

Hon Yuen, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 8, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2025-08-08.