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Stepped Care for Aphasia
N/A
Waitlist Available
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 10 weeks
Awards & highlights
Study Summary
This trial studies how psychological well-being treatments can help people with aphasia caused by stroke. Participants receive testing, 5-week treatment, post-testing & 1-mo follow-up. Compensated for participation.
Who is the study for?
This trial is for stroke survivors aged 18-81 who developed aphasia, a language impairment, at least one month post-stroke. They must be native English speakers with confirmed left hemisphere stroke and able to consent. Excluded are those with severe hearing or vision issues, other neurological disorders besides stroke, premorbid learning disabilities, or severe auditory comprehension deficits.Check my eligibility
What is being tested?
The study tests a psychosocial intervention designed to improve the psychological well-being of individuals with aphasia following a stroke. Participants will undergo initial testing, receive treatment over five weeks, have follow-up assessments immediately after and one month later, including check-in calls and an interview about their experience.See study design
What are the potential side effects?
Since this is a psychosocial intervention focusing on mental health support rather than medication or surgery, traditional physical side effects are not expected. However emotional discomfort due to discussing personal experiences may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the Hospital Anxiety and Depression Scale at 1-Month Follow-Up
Secondary outcome measures
Change in Behavioural Outcomes of Anxiety Scale at 1-Month Follow-Up
Change in Communication Confidence Rating Scale for Aphasia at 1-Month Follow-Up
Change in Dynamic Visual Analogue Mood Scales at 1-Month Follow-Up
+3 moreSide effects data
From 2012 Phase 2 trial • 60 Patients • NCT0111718159%
Anxiety
59%
agitation
41%
Depressed mood
38%
Distractibility
38%
Dizziness
34%
weight loss
34%
Drowsiness
31%
Aggressive behavior or hostility
28%
Depressed appetite
24%
Dry mouth
21%
Arthralgia
21%
Skin rash, redness, or inflammation
21%
abdominal pain
21%
Anorexia
17%
Headache
17%
Hyperactivity
14%
Blood pressure changes
14%
Impaired learning
10%
Nausea
7%
Angina
7%
Hair loss
3%
Dyskinesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Methylphenidate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psychosocial interventionExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychosocial intervention
2014
Completed Phase 4
~1080
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,379 Total Patients Enrolled
5 Trials studying Aphasia
416 Patients Enrolled for Aphasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your medical records show that you had a stroke on the left side of your brain.You have trouble with your hearing or vision that makes it difficult for you to do the study activities.You must be between 18 and 81 years old to participate.You have trouble speaking or understanding language due to a stroke on the left side of your brain.You have a severe problem understanding spoken words.You had a stroke at least 1 month ago.You have a history of learning disability before getting sick.
Research Study Groups:
This trial has the following groups:- Group 1: Psychosocial intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies to take part in this scientific experiment?
"Candidates aged between 18 and 81 years old who have been diagnosed with aphasia can enrol in this trial. The study is open to approximately 10 individuals."
Answered by AI
Are there any vacant slots for participants in this trial?
"Affirmative, the clinical trial is still enrolling participants according to information published on clinicaltrials.gov. This study was posted on March 31st 2023 and last altered May 1st 2023. The current goal is to enrol 10 patients at a single medical centre."
Answered by AI
Does this medical research include elderly individuals aged 85 and over?
"This research has established eligibility requirements, which stipulate that participants should be between 18 to 81 years old. Simultaneously, there are 45 trials for minors and 1088 studies suitable for seniors."
Answered by AI
What is the current enrollment quota for this clinical research?
"Affirmative. According to the clinicaltrials.gov listing, this medical trial is actively recruiting participants as of May 1st 2023. It was first shared publicly on March 31st and they are looking for 10 individuals between one location."
Answered by AI
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