Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)

Kessler Foundation

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Behavioral: Placebo speed training; Behavioral: Placebo; memory exercise; Behavioral: Behavioral: speed exercises; Behavioral: Behavorial; memory exercise

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03985540

R-947-16

Details and patient eligibility

About

The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).

Full description

The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• I am between the ages of 18 and 75 years old.
• I have a spinal cord injury with the level of injury between C1-T12.
• I am non-ambulatory (I use a wheelchair as my primary means of getting around).
• I have an AIS grade of A, B or C as determined by study staff examination.
• My injury occurred at least 1 year ago.
• My primary language is English.

Exclusion criteria

• I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
• I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
• I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
• I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
• My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
• I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

104 participants in 4 patient groups, including a placebo group

memory experimental group

Experimental group

Description:

Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

Treatment:

Behavioral: Behavorial; memory exercise

Placebo comparator memory

Placebo Comparator group

Description:

Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks.

Treatment:

Behavioral: Placebo; memory exercise

Processing speed

Experimental group

Description:

Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

Treatment:

Behavioral: Behavioral: speed exercises

Processing speed placebo

Placebo Comparator group

Description:

Placebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks.

Treatment:

Behavioral: Placebo speed training