Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

Stroke Clinical Trial

Official title:

Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05162781
• Other study ID #: IRB-300008211
• Secondary ID: 1R01AG070049-01A
• Status: Recruiting
• Phase: N/A
• Start date: June 9, 2022
• Est. completion date: July 30, 2026

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: Staci McKay, BS
• Phone: 205-934-9768
• Email: stacemc[@]uab.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP).

Both CICT and BF-HELP will involve 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program.

The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis.

Participants will be randomly assigned to the interventions.

Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 30, 2026
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Primary Inclusion Criteria:

• stroke > 1 year previously

• mild-to-moderate general cognitive impairment as determined by a Montreal Cognitive Assessment (MOCA) score between 10-26

• some impairment in performance of daily activities; this will be determined by a score of 3 or below on the Cognitive Task Activity Log (CTAL)

Additional Inclusion Criteria:

• 40 years or older; no upper limit if medically stable

• sufficiently fit, from both a physical and mental health perspective, to take part in study

• adequate sight and hearing to complete UFOV test

• adequate thinking skills, e.g., ability to follow directions, retain information, to complete UFOV and CTAL, as marked by judgement of the screener that the candidate is able to adequately complete the UFOV and CTAL

• reside in the community (as opposed to a hospital or skilled nursing facility)

• able to travel to laboratory on multiple occasions

• caregiver available

Exclusion Criteria:

• cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse or due to another type of brain injury, such a traumatic brain injury, or a progressive brain disease, such as Alzheimer's Dementia

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Stroke

Intervention

Behavioral:
• Speed of Processing Training
This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.
• Instrumental Activities of Daily Living In-lab Training
The training component is thought to bridge SOPT training, which targets a basic cognitive capacity, and IADL performance in daily life. This training component will involve repeated trials in which participants will practice carrying out simulated IADL tasks in the lab under the supervision of the trainer. The training will follow shaping principles, i.e., task requirements will be made progressively more challenging, in small increments, as participants gain mastery. Frequent, positive feedback will be provided.
• Cognitive Transfer Packagke
This training component is designed to transfer improvements in cognition from the treatment setting to everyday life. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning performance of IADL as homework.
• Family Caregiver Coaching
One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.
• Follow-up Phone Calls
After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.
• Healthy Lifestyle In-lab Training
This training component is designed to promote lifestyle changes that support brain fitness. Participants will receive education and coaching in the lab on relaxation, healthy nutrition, and healthy sleep.
• Healthy Lifestyle Transfer Package
This training component is designed to support integration into everyday life of the lifestyle changes training in the lab. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning relaxation exercises, for example, as homework.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute on Aging (NIA), Posit Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale	The Neuro-QOL assesses function in daily life in several domains; it is a widely used, validated, transdiagnostic, self-report measure. The development and use of the Neuro-QOL is supported by the National Institutes of Health. The component of the Neuro-QOL that assessed cognitive function will be used here. Items are rated by respondents using a five-point scale: 1 = not at all, 5 = very much. Higher scores indicate better function.	Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment