COMPLETED

Accelerated rTMS for Post-Stroke Apathy

Conditions

Apathy Stroke Sequelae Stroke (CVA) or TIA Stroke/Brain Attack Motivation Abulia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This pilot study will investigate the safety, feasibility, tolerability, and preliminary efficacy of accelerated high-dose repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC) to address apathy symptoms in individuals with chronic stroke.

Official Title

Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement

Quick Facts

Study Start:2023-12-01

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05878457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 40 years old or greater 2. Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity 3. Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale (AES) of ≥39 as rated by the participant or caregiver informant 4. Intact cortex under the coil at the stimulation target site confirmed by neuroimaging 5. Ability to participate in psychometric testing and cognitive tasks	1. Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage 2. Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia) 3. Moderate or severe global aphasia 4. Visual impairment precluding completion of cognitive tasks 5. Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemakers, intracerebral vascular clips, or any other electrically sensitive support system; 6. Pregnancy (to be later confirmed by UPT in any premenopausal female participants) 7. History of a seizure disorder 8. Preexisting scalp lesion, wound, bone defect, or hemicraniectomy 9. Claustrophobia precluding the ability to undergo an MRI 10. Active substance use disorder 11. Psychotic disorders 12. Bipolar 1 Disorder 13. Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year

Inclusion Criteria

Exclusion Criteria

1. 40 years old or greater
2. Right- or left-hemisphere ischemic or hemorrhagic stroke with at least 6 months chronicity
3. Symptomatic apathy as confirmed by (A) total score on the Apathy Evaluation Scale (AES) of ≥39 as rated by the participant or caregiver informant
4. Intact cortex under the coil at the stimulation target site confirmed by neuroimaging
5. Ability to participate in psychometric testing and cognitive tasks

1. Primary extra-axial hemorrhage (subdural or subarachnoid) without ischemic stroke or intraparenchymal hemorrhage
2. Concomitant neurological disorders affecting motor or cognitive function (e.g. dementia)
3. Moderate or severe global aphasia
4. Visual impairment precluding completion of cognitive tasks
5. Presence of contraindications to MRI or TMS including electrically, magnetically or mechanically activated metal or nonmetal implants such as cardiac pacemakers, intracerebral vascular clips, or any other electrically sensitive support system;
6. Pregnancy (to be later confirmed by UPT in any premenopausal female participants)
7. History of a seizure disorder
8. Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
9. Claustrophobia precluding the ability to undergo an MRI
10. Active substance use disorder
11. Psychotic disorders
12. Bipolar 1 Disorder
13. Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year

Contacts and Locations

Principal Investigator

Parneet Grewal, MD

PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Study Locations (Sites)

Medical University of South Carolina Brain Stimulation Lab

Charleston, South Carolina, 29403

United States

Collaborators and Investigators

Sponsor: Medical University of South Carolina

Parneet Grewal, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-12-01

Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

Apathy
Stroke Sequelae
Stroke (CVA) or TIA
Stroke/Brain Attack
Motivation
Abulia