BridgeMD
New treatment option for Apathy
Official title Accelerated rTMS vs. Sham for Stroke Apathy
ClinicalTrials.gov ID: NCT07113067
What this study is testing
- What it's testing
- 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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
See the full eligibility 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.