ApathyPhase 1NCT05878457

Accelerated rTMS for Post-Stroke Apathy

A Phase 1 study testing MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System in people with Apathy and Stroke Sequelae, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Apathy, Stroke Sequelae, Stroke (CVA) or TIA
What is being tested?: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to 30 Apr 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 (AES) of ≥39 as rated by the participant or caregiver informant
Intact cortex under the coil at the stimulation target site confirmed by neuroimaging
Ability to participate in psychometric testing and cognitive tasks

Who cannot join

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 pacemakers, intracerebral vascular clips, or any other electrically sensitive support system;
Pregnancy (to be later confirmed by UPT in any premenopausal female participants)

Show all 13Show fewer

History of a seizure disorder
Preexisting scalp lesion, wound, bone defect, or hemicraniectomy
Claustrophobia precluding the 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) or suicide attempt in the previous year

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina Brain Stimulation Lab
Charleston, South Carolina, 29403

Other trials in United States

About this study

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

Read the detailed description

Repetitive transcranial magnetic stimulation (rTMS) is a well-established FDA-approved treatment for several psychiatric indications including treatment-resistant depression, obsessive-compulsive disorder, and smoking cessation. Traditional rTMS targets the dorsolateral prefrontal cortex (dlPFC) with repetitive treatments delivered for six weeks. Recent innovations have led to the development of accelerated, high-dose rTMS protocols, with recent FDA-approval, that are capable of delivering a full treatment course within a single week.

Accumulating evidence suggests that similar neuromodulation protocols may be helpful in targeting neuropsychiatric symptoms across a range of neurologic and neurodegenerative conditions including dementia, movement disorders, and stroke. Apathy is a distinct neuropsychiatric symptom characterized by loss of motivation, withdrawal, and decreased goal-directed activity seen across a wide range of neuropsychiatric conditions. Apathy contributes significantly to lower quality of life, caregiver burnout, and poorer rehabilitation outcomes. Meanwhile, there are currently no FDA-approved treatments targeting apathy specifically. The mPFC has been well-established as a safe and feasible target for traditional rTMS, and may be a desirable stimulation site in targeting apathy due to its superficial location and integral association with other brain structures implicated in apathy pathophysiology such as the anterior cingulate cortex (ACC) and ventral striatum (VL).

This phase I open-label pilot study will investigate high-dose, accelerated rTMS at the medial prefrontal cortex (mPFC) to target apathy in individuals with chronic stroke. The primary aims of the study will be to: (1) establish the safety, feasibility, tolerability, and acceptability of an accelerated repetitive transcranial magnetic stimulation (rTMS) protocol for apathy in chronic stroke; (2) establish the feasibility of individualized resting-state functional magnetic resonance imaging (fMRI) connectivity for targeting rTMS in post-stroke apathy; (3) establish preliminary efficacy of an accelerated rTMS protocol for post-stroke apathy. Given the limited power of this small pilot study, this aim will be considered exploratory with the intention to guide future research.

Sixteen chronic stroke patients with symptomatic apathy will complete (1) structural as well as resting state functional MRI at baseline for targeting parcellations. (2) A battery of validated clinical assessments of apathy-related symptoms (3) a battery of neuropsychological, cognitive, and symptom measures to assess safety, tolerability, and feasibility. Treatment will consist of open-label, high-dose rTMS to left mPFC delivered following a standard protocol consisting of 600 pulses, twelve times per day, for three treatment days (contiguous or non-contiguous) within a seven-day period. Safety assessments will be monitored throughout treatment. A battery of clinical assessments will be repeated at the end of treatment and weekly for one month post-treatment.

Conditions: Apathy, Stroke Sequelae, Stroke (CVA) or TIA, Stroke/Brain Attack, Motivation, Abulia
Being tested: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System
Medical subject headings: Lethargy, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MagVenture MagPro Transcranial Magnetic Stimulation (TMS) SystemDevice
Also called Brainsight Neuronavigation System
Treatment will consist 12 approximately-three-minute sessions on each of three treatment days within a seven-day period. To promote participant adherence and retention, treatment days will not need to be contiguous. A single session consists of 600 pulses delivered to the dmPFC at an intensity of 120% resting motor threshold (rMT). 50 hz triphasic bursts will be delivered for two seconds, followed by an 8 second inter-train interval. Trains will be repeated every 10 seconds, 10 times total, for a total of 190 seconds per session. An intersession interval of at least 15 minutes will be employed between each of the 12 sessions. Each treatment day will thus last approximately 3-4 hours in duration.

Study groups in NCT05878457
Study group	Role	What they receive
Repetitive transcranial magnetic stimulation	Experimental	All participants will receive accelerated, high-dose repetitive transcranial magnetic stimulation (rTMS) at the medial prefrontal cortex (mPFC) delivered in runs of 600 pulses, twelve times per day, for three treatment days (contiguous or non-contiguous) within a seven-day period. Receives: Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline
The Lille Apathy Rating Scale (LARS) is a validated 33-item structured interview assessing apathy across 9 domains, including intellectual curiosity, emotion, action initiation, self-awareness, productivity, interests, novelty seeking, motivation, and social engagement.
Total scores range from -36 to +36, with higher scores indicating greater severity of apathy (worse outcome) and lower (more negative) scores indicating less apathy (better outcome).
The total score is calculated by summing responses across all items and domains to generate a composite score.
Measured: Pre-treatment, immediately post-treatment, and at one-month follow-up
Treatment-Emergent Adverse Events and Side Effects as Assessed by Intermittent Theta Burst Stimulation Review of Systems (iTBS ROS)
A review of systems questionnaire (Intermittent Theta Burst Stimulation Review of Systems; iTBS ROS) was administered repeatedly during each treatment day to assess treatment-emergent symptoms.
Symptoms were rated on a scale from 0 to 5 (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, 5 = severe), with higher scores indicating greater symptom severity (worse outcome).
Values reported represent the average symptom severity across all assessments collected during the 3 treatment days for each participant, and then averaged across participants.
Measured: Across the 3 rTMS treatment days
Change in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) Compared to Baseline
The Montreal Cognitive Assessment (MoCA) is a clinical assessment of cognitive function. The MoCA assesses multiple cognitive domains including memory, visuospatial skills, executive function, attention, concentration, calculation, language, abstraction, and orientation. The MoCA can be administered in approximately 10 minutes and total scores range from 0 to 30 with lower scores correlating with greater degree of cognitive impairment.
Measured: Pre-treatment, immediately post-treatment, and at one-month follow-up
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery Compared to Baseline
Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 5 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, dimensional change card sort tests, and picture sequence memory. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. There are no established thresholds or cutoffs for clinically distinct or diagnostic categories.
Measured: Pre-treatment, immediately post-treatment
Participant Retention Rate
Percentage of participants who completed the study relative to all participants who initiated treatment
Measured: calculated at the end of the study follow-up assessment period (one month post-treatment)

Secondary outcomes (2)

Change in Apathy Symptoms, as Measured by the Apathy Evaluation Scale (AES) Compared to Baseline
The Apathy Evaluation Scale (AES) clinically validated rating scale assessing symptoms of apathy. The AES is comprised of 18 items rated on a four-point Likert-Scale assessing and quantifying emotional, behavioral and cognitive aspects of apathy. Total scores on the AES range from 18 to 72 with high scores correlating with greater severity of apathy.
Measured: Pre-treatment, immediately post-treatment, and at one-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
The Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form is a validated patient-reported outcome measure assessing depressive symptoms, including negative mood, cognitive symptoms, and decreased positive affect.
Scores are reported as T-scores standardized to the U.S. general population, where a T-score of 50 represents the population mean and 10 represents the standard deviation.
Higher T-scores indicate greater depressive symptom severity (worse outcome), while lower T-scores indicate fewer depressive symptoms (better outcome).
T-scores of approximately 60 or greater are generally considered indicative of at least mild clinically elevated depressive symptoms, with higher thresholds reflecting increasing severity.
Measured: Pre-treatment, immediately post-treatment, and at one-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202330 Apr 2025

First posted26 May 2023
Study start1 Dec 2023
Primary completion30 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for ApathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Model description: single group, open-label pilot investigation
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05878457
Sponsor's protocol ID: Pro00126436
Status last verified: Jun 2026
First submitted: 20 Apr 2023
Last updated: 10 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Le Heron C, Apps MAJ, Husain M. The anatomy of apathy: A neurocognitive framework for amotivated behaviour. Neuropsychologia. 2018 Sep;118(Pt B):54-67. doi: 10.1016/j.neuropsychologia.2017.07.003. Epub 2017 Jul 8.
PubMed 28689673
Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.
PubMed 16207933
Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. doi: 10.1002/da.20731.
PubMed 20734360
Sasaki N, Hara T, Yamada N, Niimi M, Kakuda W, Abo M. The Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation for Improving Apathy in Chronic Stroke Patients. Eur Neurol. 2017;78(1-2):28-32. doi: 10.1159/000477440. Epub 2017 Jun 3.
PubMed 28578330
Santa N, Sugimori H, Kusuda K, Yamashita Y, Ibayashi S, Iida M. Apathy and functional recovery following first-ever stroke. Int J Rehabil Res. 2008 Dec;31(4):321-6. doi: 10.1097/MRR.0b013e3282fc0f0e.
PubMed 19008681
Jorge RE, Starkstein SE, Robinson RG. Apathy following stroke. Can J Psychiatry. 2010 Jun;55(6):350-4. doi: 10.1177/070674371005500603.
PubMed 20540829
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019
Sockeel P, Dujardin K, Devos D, Deneve C, Destee A, Defebvre L. The Lille apathy rating scale (LARS), a new instrument for detecting and quantifying apathy: validation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2006 May;77(5):579-84. doi: 10.1136/jnnp.2005.075929.
PubMed 16614016
Casaletto KB, Umlauf A, Beaumont J, Gershon R, Slotkin J, Akshoomoff N, Heaton RK. Demographically Corrected Normative Standards for the English Version of the NIH Toolbox Cognition Battery. J Int Neuropsychol Soc. 2015 May;21(5):378-91. doi: 10.1017/S1355617715000351. Epub 2015 Jun 1.
PubMed 26030001
Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27.
PubMed 26931289
Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. doi: 10.1016/0165-1781(91)90040-v.
PubMed 1754629
Seidman MB, Grewal P, Bowyer C, Dickens I, Eade J, Collins E, Patel C, Arias Velasquez DE, George MS, Antonucci M, Caulfield KA, McTeague LM. Improving Motivation in Post-stroke Apathy with Repetitive Transcranial Magnetic Stimulation (IMPART): A Phase-I Pilot Trial. medRxiv [Preprint]. 2026 Jun 5:2026.06.01.26354398. doi: 10.64898/2026.06.01.26354398.
PubMed 42282206

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Apathy trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accelerated rTMS for Post-Stroke Apathy: Targeting Amotivation Toward Improving Whole Health and Rehabilitation Engagement
ClinicalTrials.gov ID: NCT05878457
Acronym / sponsor ID: Pro00126436
Conditions: Apathy, Stroke Sequelae, Stroke (CVA) or TIA, Stroke/Brain Attack, Motivation, Abulia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 26 May 2023 (actual)
Results: Posted 10 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: single group, open-label pilot investigation

Arm	Type	Receives
Repetitive transcranial magnetic stimulation	Experimental	Device: MagVenture MagPro Transcranial Magnetic Stimulation (TMS) SystemAll participants will receive accelerated, high-dose repetitive transcranial magnetic stimulation (rTMS) at the medial prefrontal cortex (mPFC) delivered in runs of 600 pulses, twelve times per day, for three treatment days (contiguous or non-contiguous) within a seven-day period.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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 (AES) of ≥39 as rated by the participant or caregiver informant
Intact cortex under the coil at the stimulation target site confirmed by neuroimaging
Ability to participate in psychometric testing and cognitive tasks

Key exclusion criteria (13 listed)

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 pacemakers, intracerebral vascular clips, or any other electrically sensitive support system;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MagVenture MagPro Transcranial Magnetic Stimulation (TMS) SystemAlso: Brainsight Neuronavigation SystemTreatment will consist 12 approximately-three-minute sessions on each of three treatment days within a seven-day period. To promote participant adherence and retention, treatment days will not need to be contiguous. A single session consists of 600 pulses delivered to the dmPFC at an intensity of 120% resting motor threshold (rMT). 50 hz triphasic bursts will be delivered for two seconds, followed by an 8 second inter-train interval. Trains will be repeated every 10 seconds, 10 times total, for a total of 190 seconds per session. An intersession interval of at least 15 minutes will be employed between each of the 12 sessions. Each treatment day will thus last approximately 3-4 hours in duration.	Device	Repetitive transcranial magnetic stimulation

Primary outcome

Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline
Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up
The Lille Apathy Rating Scale (LARS) is a validated 33-item structured interview assessing apathy across 9 domains, including intellectual curiosity, emotion, action initiation, self-awareness, productivity, interests, novelty seeking, motivation, and social engagement. Total scores range from -36 to +36, with higher scores indicating greater severity of apathy (worse outcome) and lower (more negative) scores indicating less apathy (better outcome). The total score is calculated by summing responses across all items and domains to generate a composite score.
Treatment-Emergent Adverse Events and Side Effects as Assessed by Intermittent Theta Burst Stimulation Review of Systems (iTBS ROS)
Time frame: Across the 3 rTMS treatment days
A review of systems questionnaire (Intermittent Theta Burst Stimulation Review of Systems; iTBS ROS) was administered repeatedly during each treatment day to assess treatment-emergent symptoms. Symptoms were rated on a scale from 0 to 5 (0 = none, 1 = minimal, 2 = mild, 3 = moderate, 4 = marked, 5 = severe), with higher scores indicating greater symptom severity (worse outcome). Values reported represent the average symptom severity across all assessments collected during the 3 treatment days for each participant, and then averaged across participants.
Change in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) Compared to Baseline
Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up
The Montreal Cognitive Assessment (MoCA) is a clinical assessment of cognitive function. The MoCA assesses multiple cognitive domains including memory, visuospatial skills, executive function, attention, concentration, calculation, language, abstraction, and orientation. The MoCA can be administered in approximately 10 minutes and total scores range from 0 to 30 with lower scores correlating with greater degree of cognitive impairment.
Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery Compared to Baseline
Time frame: Pre-treatment, immediately post-treatment
Fluid cognition was measured using the iPad-administered NIH Toolbox Cognition Battery (NIHTB-CB). Fluid Cognition Composite scores were calculated by averaging the demographically adjusted (age, education, sex, race/ethnicity; Casaletto et al., 2015) T-scores for 5 NIHTB-CB tests: the flanker inhibitory control, list sorting working memory, pattern comparison processing speed, dimensional change card sort tests, and picture sequence memory. T-Scores have a mean of 50 and a standard deviation of 10. Lower scores indicate worse performance. There are no established thresholds or cutoffs for clinically distinct or diagnostic categories.
Participant Retention Rate
Time frame: calculated at the end of the study follow-up assessment period (one month post-treatment)
Percentage of participants who completed the study relative to all participants who initiated treatment

2 secondary outcomes

Change in Apathy Symptoms, as Measured by the Apathy Evaluation Scale (AES) Compared to Baseline
Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form
Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up

Results and safety

Results posted to the registry on 10 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Repetitive Transcranial Magnetic Stimulation	15	14

Primary outcome: Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline

Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up. Mean (Standard Deviation). Unit: scores on a scale

Measure	Repetitive Transcranial Magnetic Stimulation n = 14
Pre-treatment	-20.86 (8.56)
Immediate post-treatment	-23.36 (5.89)
One-month follow-up	-26.86 (5.04)

Primary outcome: Treatment-Emergent Adverse Events and Side Effects as Assessed by Intermittent Theta Burst Stimulation Review of Systems (iTBS ROS)

Time frame: Across the 3 rTMS treatment days. Mean (Standard Deviation). Unit: scores on a scale

Measure	Repetitive Transcranial Magnetic Stimulation n = 14
Headache, treatment day 1	0 (0)
Headache, treatment day 2	1.21 (1.72)
Headache, treatment day 3	0.71 (1.44)
Scalp pain, treatment day 1	0.00 (0.00)
Scalp pain, treatment day 2	1.21 (1.72)
Scalp pain, treatment day 3	0.00 (0.00)
Arm/hand pain, treatment day 1	1.07 (1.69)
Arm/hand pain, treatment day 2	1.29 (1.77)

Primary outcome: Change in Global Cognition, as Measured by the Montreal Cognitive Assessment (MoCA) Compared to Baseline

Time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up. Mean (Standard Deviation). Unit: scores on a scale

Measure	Repetitive Transcranial Magnetic Stimulation n = 14
Pre-treatment	24.50 (3.23)
Immediate post-treatment	25.00 (3.67)
One-month follow-up	25.20 (3.56)

Primary outcome: Change From Baseline Cognition, as Measured by the Fluid Cognition Composite Score From the NIH Toolbox Cognition Battery Compared to Baseline

Time frame: Pre-treatment, immediately post-treatment. Mean (Standard Deviation). Unit: T-score

Measure	Repetitive Transcranial Magnetic Stimulation n = 14
Pre-treatment	35.67 (13.44)
Immediate post-treatment	40.25 (16.92)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment to the end of follow up, up to 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Repetitive Transcranial Magnetic Stimulation	0 of 15 (0%)	13 of 15 (86.7%)	0 of 15

Limitations and caveats (from the sponsor): 1. Open-label, single-arm design limits causal inference and does not allow separation of treatment effects from expectancy or placebo effects. 2. Limited sample size and relatively homogeneous participant population demographics may limit generalizability 3. Heterogeneity of stroke type, location, and laterality may introduce variability

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28689673Le Heron C, Apps MAJ, Husain M. The anatomy of apathy: A neurocognitive framework for amotivated behaviour. Neuropsychologia. 2018 Sep;118(Pt B):54-67. doi: 10.1016/j.neuropsychologia.2017.07.003. Epub 2017 Jul 8.
Background: PubMed 16207933Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.
Results publication: PubMed 20734360Holtzheimer PE 3rd, McDonald WM, Mufti M, Kelley ME, Quinn S, Corso G, Epstein CM. Accelerated repetitive transcranial magnetic stimulation for treatment-resistant depression. Depress Anxiety. 2010 Oct;27(10):960-3. doi: 10.1002/da.20731.
Results publication: PubMed 28578330Sasaki N, Hara T, Yamada N, Niimi M, Kakuda W, Abo M. The Efficacy of High-Frequency Repetitive Transcranial Magnetic Stimulation for Improving Apathy in Chronic Stroke Patients. Eur Neurol. 2017;78(1-2):28-32. doi: 10.1159/000477440. Epub 2017 Jun 3.
Results publication: PubMed 19008681Santa N, Sugimori H, Kusuda K, Yamashita Y, Ibayashi S, Iida M. Apathy and functional recovery following first-ever stroke. Int J Rehabil Res. 2008 Dec;31(4):321-6. doi: 10.1097/MRR.0b013e3282fc0f0e.
Results publication: PubMed 20540829Jorge RE, Starkstein SE, Robinson RG. Apathy following stroke. Can J Psychiatry. 2010 Jun;55(6):350-4. doi: 10.1177/070674371005500603.
Results publication: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Results publication: PubMed 16614016Sockeel P, Dujardin K, Devos D, Deneve C, Destee A, Defebvre L. The Lille apathy rating scale (LARS), a new instrument for detecting and quantifying apathy: validation in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2006 May;77(5):579-84. doi: 10.1136/jnnp.2005.075929.
Results publication: PubMed 26030001Casaletto KB, Umlauf A, Beaumont J, Gershon R, Slotkin J, Akshoomoff N, Heaton RK. Demographically Corrected Normative Standards for the English Version of the NIH Toolbox Cognition Battery. J Int Neuropsychol Soc. 2015 May;21(5):378-91. doi: 10.1017/S1355617715000351. Epub 2015 Jun 1.
Results publication: PubMed 26931289Schalet BD, Pilkonis PA, Yu L, Dodds N, Johnston KL, Yount S, Riley W, Cella D. Clinical validity of PROMIS Depression, Anxiety, and Anger across diverse clinical samples. J Clin Epidemiol. 2016 May;73:119-27. doi: 10.1016/j.jclinepi.2015.08.036. Epub 2016 Feb 27.
Results publication: PubMed 1754629Marin RS, Biedrzycki RC, Firinciogullari S. Reliability and validity of the Apathy Evaluation Scale. Psychiatry Res. 1991 Aug;38(2):143-62. doi: 10.1016/0165-1781(91)90040-v.
Derived from this study: PubMed 42282206Seidman MB, Grewal P, Bowyer C, Dickens I, Eade J, Collins E, Patel C, Arias Velasquez DE, George MS, Antonucci M, Caulfield KA, McTeague LM. Improving Motivation in Post-stroke Apathy with Repetitive Transcranial Magnetic Stimulation (IMPART): A Phase-I Pilot Trial. medRxiv [Preprint]. 2026 Jun 5:2026.06.01.26354398. doi: 10.64898/2026.06.01.26354398.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Parneet Grewal, MD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Apathy Symptoms, as Measured by the Lille Apathy Rating Scale (LARS) Compared to Baseline (time frame: Pre-treatment, immediately post-treatment, and at one-month follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05878457, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.