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RecruitingPhase 1 / Phase 2

Accelerated rTMS vs. Sham for Stroke Apathy

Accelerated rTMS for Post-stroke Apathy: A Double-blind Randomized Controlled Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days
  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In a separate ongoing dose-response study in the MUSC Brain Stimulation Lab, accelerated iTBS to left dlPFC was applied for up to 10 sessions per day for 5 days, maximum 50 active sessions, 30,000 individual total pulses among individuals with moderate to severe anxiety and depression."
  • "Brain MRIs will be collected at pre- and immediately post-treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a fast form of rTMS, a treatment that uses magnets to stimulate the brain, against a sham (inactive) treatment. It is for adults age 40 or older who have apathy—loss of motivation—after a stroke. Researchers want to learn if the treatment is safe, comfortable, and helpful.

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40 or older.
  • You had a stroke from a blocked blood vessel or bleeding on either side of the brain at least 6 months ago.
  • You have apathy, with a score of 39 or higher on a survey filled out by you or your caregiver.
  • You can take part in tests of thinking and other mental skills.
  • An MRI brain scan shows that the brain’s outer layer is intact where treatment will be given.
  • You have a caregiver or study partner who meets the study rules.
  • Your caregiver or study partner is at least 18, has contact with you at least weekly, and can reliably describe your thinking and daily activities.

Who can't join

  • You had bleeding around the brain only, without a stroke from a blocked blood vessel or bleeding within the brain.
  • You have another brain or nerve condition that affects movement or thinking, such as dementia.
  • You have moderate or severe trouble both speaking and understanding language, or vision problems that prevent thinking tests.
  • MRI or TMS is unsafe for you, such as because of certain implants, or fear of tight spaces prevents an MRI.
  • You are pregnant or have a history of a seizure disorder.
  • You have a scalp sore or wound, a skull defect, or part of your skull has been removed.
  • You have a current substance use disorder, a disorder involving loss of touch with reality, bipolar I disorder, current suicide risk, or a suicide attempt in the past year.
  • Your caregiver or study partner cannot take part in study steps that need their input.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

SC