Accelerated rTMS vs. Sham for Stroke Apathy

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorMedical University of South Carolina

About this trial

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 Apathy occurs when a person has lost motivation, becomes withdrawn, and stops doing things that used to be important to them.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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Active)
  • MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System (Sham)
  • Brainsight Neuronavigation System

Treatment groups

40 Participants
are divided into 2 treatment groups