Accelerated rTMS vs. Sham for Stroke Apathy
Recruiting · NCT07113067 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of South Carolina
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Apathy is a common set of symptoms seen in many people following a stroke. Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them. Apathy has a large negative impact on a person's quality of life, and can also have a large impact the people who take care of them. There are currently no FDA-approved treatments to help with apathy, and other services like therapy may be difficult to access for people who have had a stroke. To address this problem, investigators are conducting a study to find out if a form of treatment called repetitive transcranial magnetic stimulation (rTMS) can be safe and helpful for people struggling with apathy after a stroke. This study will apply a new form of rTMS which can be delivered quickly to a part of the brain called the medial prefrontal cortex (mPFC). This study will help establish whether this treatment is safe, comfortable, and effective for people with apathy after a stroke, and will help researchers develop new forms of treatment.
Who can take part
Inclusion criteria
- 40 years old or greater
- Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
- Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥39
- Ability to participate in psychometric testing and cognitive tasks
- Intact cortex at the TMS target site as confirmed by pre-treatment MRI
- Ability to have a co-participant/caregiver who meets the criteria as detailed below.
Exclusion criteria
- Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
- Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
- Moderate or severe global aphasia
- Visual impairment precluding completion of cognitive tasks
- Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system;
- Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
- History of a seizure disorder
- Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
- Claustrophobia precluding ability to undergo an MRI
- Active substance use disorder
- Psychotic disorders
- Bipolar 1 Disorder
- Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)30 or suicide attempt in the previous year
- For CO-PARTICIPANT/CAREGIVER:
- Inclusion Criteria:
- Age 18 years or older
- Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's cognitive and everyday functioning.
- Exclusion Criteria:
- \- Unable to engage with study procedures in which Co-Participant input is needed.
Where it is running
1 location listed across 1 US state.
- Medical University of South Carolina Brain Stimulation Lab - Charleston, South Carolina, United States