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Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation

NCT05017857 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-02-28

No results posted yet for this study

Summary

The objectives of this pilot project are to determine whether pairing rTMS with an evidence-based PST intervention is acceptable to and feasible for individuals with executive function deficits after stroke and whether rTMS enhances executive functioning and uptake of the PST intervention to improve generalization of the PST strategy and support long-term goal attainment. To achieve the objectives, the investigators propose two specific aims:

AIM 1: Establish the acceptability and feasibility of delivering up to 6 sessions of PST+ rTMS to individuals with executive function deficits ≥ 6 months post stroke. Hypothesis 1a:80% participants will complete 6 PST sessions. Hypothesis 1b: 1b: Participants who receive rTMS directly prior to the PST intervention will report higher satisfaction with the overall intervention compared to those who receive rTMS simultaneously with PST.

AIM 2: Assess the initial efficacy of PST+rTMS for improving patient outcomes in individuals with stroke. Hypothesis 2a Patients will demonstrate a significant increase in executive functioning (ie. attention, immediate memory and cognitive flexibility and reasoning) as measured by the Digit Span Test and Wisconsin Card Sorting Test. Hypothesis 2b: Patients will achieve 80% of self-set goals. Hypothesis 2c: Patients will demonstrate a significant increase in task-oriented coping skills as measured by the Brief Cope at 1-month post intervention.

Conditions

Interventions

DEVICE

RepetiveTranscrainal Magnetic Stimulation (rTMS)

RepetiveTranscrainal Magnetic Stimulation (rTMS): rTMS is a non-invasive electromagnetic stimulation of the brain. A train of electric pulses is delivered at the same intensity over a set period of time to a targeted region of the brain. The current stimulates or suppresses neuronal activity based on the frequency and inter-train interval between the pulses.

BEHAVIORAL

Problem-Solving Training (PST)

Problem-Solving Training (PST) is a metacognitive strategy training in which patients are guided through a process of conscious self-assessment resulting in problem identification, generation of solutions, development of specific goals and action plans, and evaluation and revision of plans as needed. PST thus helps to circumvent impulsive or unrealistic problem-solving attempts that lead to failure, discouragement, and feelings of helplessness.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-09-30
Completion
2023-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05017857 on ClinicalTrials.gov