Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation

NCT05017857 | Withdrawn

• 1 other identifier: UTSW 2021-0003
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Stroke

Outcome Measures

Primary Outcomes (8)

• Total number of sessions completed

  The primary outcome to assess feasibility is total number of sessions completed, with a threshold of 90% completing a minimum of 6 sessions at the specified rTMS intensity as an indicator of feasibility.

  Baseline to 1 month followup

• Client Satisfaction Questionnaire-8 (CSQ-8) item mean score

  The primary outcome for acceptability is satisfaction, with a Client Satisfaction Questionnaire-8 item mean of \>3.5 as an indicator of high satisfaction. CSQ-8 is a standardized assessment of client satisfaction with an intervention. Scores range from 8-32. A higher scores indicates a better outcome.

  Baseline to 1 month followup

• Changes in coping style as measured by the Coping Orientation to Problems Experienced-Brief (Brief Cope)

  To test the first hypothesis, the investigators will use intent-to-treat analyses to measure pre-post-test differences in coping between baseline and final intervention session using paired t-tests or Wilcoxon signed rank test. The Brief Cope is a 28 item self-reported questionnaire that measures effective and ineffective ways to cope with life events that cause stress. The assessment measures the degree to which a person utilizes a specific coping strategy.

  Baseline to 1 month followup

• Percentage of attained goals using Goal Attainment Scaling (GAS)

  To test the second hypothesis, the investigators will calculate the total percentage of attained goals (Goal Attainment Scaling outcome level \>"as expected") out of all attempted goals for each participant. GAS is a method for developing patient-centered goals and measuring goal achievement. GAS has been found to be a valid, reliable and sensitive measure of goal attainment in an IRU population. GAS scale (-2, achieved less than expected outcome; -1, achieved somewhat less; 0, achieved expected level; +1, achieved somewhat more; +2, achieved much more)

  Baseline to 1 month followup

• PST session completed or not

  The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no

  baseline to up to 8 weeks

• Reasons for non-completion

  The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). descriptive, no scores

  baseline up to 8 weeks

• Need to reduce rTMS intensity

  The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no

  baseline up to 8 weeks

• report of side effects

  The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no

  baseline up to 8 weeks

Secondary Outcomes (4)

• Changes in general self efficacy as measured by the General self-efficacy scale (GSE)

  baseline to 1 month follow-up

• Measure of intervention uptake as measured by the uptake questionnaire

  baseline up to 8 weeks

• Changes in attention and working memory as measured by the Digi-Span Test

  baseline up to 8 weeks

• Changes in executive function as measured by the Wisconsin Card Sorting Test (WCST)

  baseline up to 8 weeks

Study Arms (2)

Simultaneous rTMS and PST

EXPERIMENTAL

Device: RepetiveTranscrainal Magnetic Stimulation (rTMS); Behavioral: Problem-Solving Training (PST)

Sequential rTMS and PST

EXPERIMENTAL

Device: RepetiveTranscrainal Magnetic Stimulation (rTMS); Behavioral: Problem-Solving Training (PST)

Interventions

RepetiveTranscrainal Magnetic Stimulation (rTMS) DEVICE

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.

Sequential rTMS and PST; Simultaneous rTMS and PST

Problem-Solving Training (PST) BEHAVIORAL

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.

Sequential rTMS and PST; Simultaneous rTMS and PST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 6 months since stroke
• English fluency
• \>= 18 years old
• executive function deficits present (BTACT z-score based on age must fall between -1.3 and 1.3 SD)
• capacity of patient to self-consent.

You may not qualify if:

• severe aphasia (clinical judgement of inability to complete BTACT secondary to expressive/receptive aphasia)
• severe depression (Patient Health Questionnaire-8 \< 15)
• self-reported dementia diagnosis, (4) contraindications of rTMS such as pacemaker implantation, history of epilepsy, major head trauma or seizures
• use of pharmacologic agents targeting stroke-related cognitive deficits.
• All subjects must be screened for contraindications to TMS before any TMS can be performed. Subjects will be screened for known risk factors for seizure with rTMS using the TMS Adult Safety Screen (TASS) questionnaire.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 24, 2021
• Study Start: January 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share