NCT03985540

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2017

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

6 years

First QC Date

August 15, 2017

Last Update Submit

January 16, 2023

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

  • California Verbal Learning Test

    California Verbal Learning TestPerformance on a memory test using the

    Assessments will look at change over 6 weeks of treatment and 3 months after completion

Secondary Outcomes (1)

  • SCI Quality of Life Scale

    Assessments will look at change over 6 weeks of treatment and 3 months after completion

Other Outcomes (1)

  • Symbol-Digit Modalities Test (oral form)

    Assessments will look at change over 6 weeks of treatment and 3 months after completion

Study Arms (4)

memory experimental group

EXPERIMENTAL

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

Behavioral: Behavorial; memory exercise

Placebo comparator memory

PLACEBO COMPARATOR

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

Behavioral: Placebo; memory exercise

Processing speed

EXPERIMENTAL

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

Behavioral: Behavioral: speed exercises

Processing speed placebo

PLACEBO COMPARATOR

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

Behavioral: Placebo speed training

Interventions

Behavorial; memory exerciseBEHAVIORAL

Memory training twice a week for 5 weeks.

memory experimental group
Placebo; memory exerciseBEHAVIORAL

Placebo Memory training twice a week for 5 weeks

Placebo comparator memory
Behavioral: speed exercisesBEHAVIORAL

Speed training twice a week for 5 weeks.

Processing speed
Placebo speed trainingBEHAVIORAL

Placebo Speed training twice a week for 5 weeks.

Processing speed placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Richard Green, PhD

    Kessler Foundation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director NNL & TBI

Study Record Dates

First Submitted

August 15, 2017

First Posted

June 13, 2019

Study Start

November 16, 2016

Primary Completion

October 30, 2022

Study Completion

November 14, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

US(1)