Chronic StrokeNEPTUNENCT04655963
Brain Stimulation for Improving Cognition in Chronic Stroke (NEPTUNE)
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Chronic Stroke, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2021to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Have right hemisphere ischemic or hemorrhagic stroke within last 6 months chronicity
- Able to perform given cognitive tasks
- No metal implanted in the body
- A negative urine pregnancy test, if female subject of childbearing potential.
Who cannot join
- Primary intracerebral hematoma or subarachnoid hemorrhage
- Bi-hemispheric ischemic strokes
- Other concomitant neurological disorders affecting motor or cognitive function
- History of seizure disorder
- Preexisting scalp lesion or wound or bone defect or hemicraniectomy
- Substance use disorder
- Psychotic disorders
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke
Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. This study will test the safety as well as changes in cognitive function and brain activation with the administration of an accelerated rTMS protocol in chronic stroke.
Read the detailed description
The goal of this pilot study is to determine whether a repetitive high-dose form of non-invasive brain stimulation is a promising and safe treatment for stroke-related cognitive difficulties. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. In studies of rTMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, we are testing here whether cognitive function in individuals with chronic stroke could be improved by rTMS.
- Conditions
- Chronic Stroke
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Keywords
- stroke, rTMS, cognition
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | All participants would receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within a seven-day span. A single session=600 pulses at 120% rMT, iTBS triplets at 50 Hz for 2 s and repeated every 10 s for a total of 190 s to left dlPFC. Total pulses=14,400. Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems
This study will be demonstrating the safety of using rTMS in stroke patients by assessing adverse events and side effects using the intermittent transcranial brain stimulation (iTBS) Review of Systems questionnaire. The minimum value of the iTBS scale is 0 and the maximum is 75, the higher the score the more severe the side effects meaning a worse outcome.
Measured: Approximately 6 months.
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
This study will be demonstrating the feasibility of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by assessing retention throughout the study and using a credibility scale. The credibility scale maximum is 36 and minimum is 0, a higher ratings means higher credibility score which is a better outcome.
Measured: Approximately 6 months.
Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.
This study will be demonstrating the acceptability of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by using an rTMS acceptability scale. The acceptability scale maximum is 100 and the minimum is 0, a higher score means better outcome.
Measured: Approximately 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start14 Jan 2021
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants would receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within a seven-day span.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lisa McTeague, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655963
- Sponsor's protocol ID
- 00083136
- Other IDs
- 3P2CHD086844-04S1
- Acronym
- NEPTUNE
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Campbell LM, Aghamoosa S, Horn O, Fleischmann HH, Lopez J, Rbeiz KS, Madden K, Antonucci M, Revuelta G, McTeague LM, Benitez A. Feasibility of Interleaving Computerized Cognitive Training With Repetitive Transcranial Magnetic Stimulation: Pilot Studies in Mild Cognitive Impairment Due to Alzheimer's Disease and Stroke. JMIR Neurotechnol. 2026 Jul 15;5:e81437. doi: 10.2196/81437. eCollection 2026.
PubMed 42459821
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation and Plasticity in Cognitive Control Neurocircuitry in Chronic Stroke
- ClinicalTrials.gov ID
- NCT04655963
- Acronym / sponsor ID
- NEPTUNE / 00083136
- Conditions
- Chronic Stroke
- Keywords
- stroke, rTMS, cognition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Few treatments are available for post-stroke rehabilitation. The current study aims to develop a novel, short-term, high-dose repetitive transcranial magnetic stimulation (rTMS) based intervention to improve post-stroke cognitive problems. This study will test the safety as well as changes in cognitive function and brain activation with the administration of an accelerated rTMS protocol in chronic stroke.
Detailed description
The goal of this pilot study is to determine whether a repetitive high-dose form of non-invasive brain stimulation is a promising and safe treatment for stroke-related cognitive difficulties. Repetitive transcranial magnetic stimulation (rTMS) is an FDA approved treatment for depression, and is used commonly to treat people for their depression. In studies of rTMS for depression and other disorders, individuals have experienced improved cognitive function. Thus, we are testing here whether cognitive function in individuals with chronic stroke could be improved by rTMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants would receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within a seven-day span.
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)All participants would receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within a seven-day span. A single session=600 pulses at 120% rMT, iTBS triplets at 50 Hz for 2 s and repeated every 10 s for a total of 190 s to left dlPFC. Total pulses=14,400. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have right hemisphere ischemic or hemorrhagic stroke within last 6 months chronicity
- Able to perform given cognitive tasks
- No metal implanted in the body
- A negative urine pregnancy test, if female subject of childbearing potential.
Key exclusion criteria (8 listed)
- Primary intracerebral hematoma or subarachnoid hemorrhage
- Bi-hemispheric ischemic strokes
- Other concomitant neurological disorders affecting motor or cognitive function
- History of seizure disorder
- Preexisting scalp lesion or wound or bone defect or hemicraniectomy
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex. | Device | Dose 1 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems
Time frame: Approximately 6 months.
This study will be demonstrating the safety of using rTMS in stroke patients by assessing adverse events and side effects using the intermittent transcranial brain stimulation (iTBS) Review of Systems questionnaire. The minimum value of the iTBS scale is 0 and the maximum is 75, the higher the score the more severe the side effects meaning a worse outcome.
Assess feasibility, of an accelerated protocol of rTMS in stroke patients looking at retention and using an rTMS a credibility questionnaire pre/post treatment.
Time frame: Approximately 6 months.
This study will be demonstrating the feasibility of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by assessing retention throughout the study and using a credibility scale. The credibility scale maximum is 36 and minimum is 0, a higher ratings means higher credibility score which is a better outcome.
Demonstrate acceptability of an accelerated protocol of rTMS in stroke patients using an acceptability of rTMS questionnaire.
Time frame: Approximately 6 months.
This study will be demonstrating the acceptability of using rapid transcranial magnetic stimulation (rTMS) in stroke patients by using an rTMS acceptability scale. The acceptability scale maximum is 100 and the minimum is 0, a higher score means better outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 42459821Campbell LM, Aghamoosa S, Horn O, Fleischmann HH, Lopez J, Rbeiz KS, Madden K, Antonucci M, Revuelta G, McTeague LM, Benitez A. Feasibility of Interleaving Computerized Cognitive Training With Repetitive Transcranial Magnetic Stimulation: Pilot Studies in Mild Cognitive Impairment Due to Alzheimer's Disease and Stroke. JMIR Neurotechnol. 2026 Jul 15;5:e81437. doi: 10.2196/81437. eCollection 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Chronic Stroke, run by Medical University of South Carolina at 1 site in United States.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Treatment-Emergent Adverse Events and Side Effects as assessed by iTBS Review of Systems (time frame: Approximately 6 months.). The study lists 3 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 NCT04655963, which also lists 1 linked publication.
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 5 Oct 2026.