Post-stroke DepressionNCT04093843
TMS for Post Stroke Depression
A study testing TMS in people with Post-stroke Depression, run by Amelia Adcock at 1 site in United States.
Trial summary
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. Read more about this study
- Who is it for?
- Ages 22 to 85 years
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2018to 30 Jun 2020
- Phase
- Interventional
- 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 22 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 22-85 years old
- Radiographic evidence of acute or subacute stroke
- Ischemic stroke diagnosed within the last 2 weeks to 6 months
- HAMD depression score 8 or greater
- Able to provide written informed consent
- Agree to participate in all study procedures
Who cannot join
- Metallic objects or neurostimulators implanted intracranially
- Stroke in the area of stimulation
- Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
- ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
- Current use of illicit substances
- Known history of epilepsy or seizure disorder
- Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.
Read the detailed description
The primary objectives of this project are as follows:
- To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
- To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.
- To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.
- Conditions
- Post-stroke Depression
- Being tested
- TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
NeuroStar TMS Therapy
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Open label single arm study to determine safety and effectiveness of TMS for post stroke depression Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: After Day 1 of rTMS treatment
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: After Day 2 of rTMS treatment
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: After Day 3 of rTMS treatment
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: After Day 4 of rTMS treatment
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: 3 months following neurostimulation
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: 6 months following neurostimulation
Number of Participants With Adverse Events
Count of Adverse Events Reported during follow up
Measured: 12 months following neurostimulation
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Measured: Depressive symptoms will be quantified before the rTMS stimulation protocol
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Measured: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Measured: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Measured: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Measured: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start24 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Post-stroke DepressionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amelia Adcock
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amelia Adcock, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093843
- Sponsor's protocol ID
- 1804090922
- Status last verified
- Apr 2022
- First submitted
- 16 Jul 2019
- Last updated
- 29 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Frey J, Najib U, Lilly C, Adcock A. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression. Front Neurol. 2020 Aug 11;11:788. doi: 10.3389/fneur.2020.00788. eCollection 2020.
PubMed 32849235
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT04093843
- Acronym / sponsor ID
- 1804090922
- Conditions
- Post-stroke Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Amelia AdcockUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 18 Sep 2019 (actual)
- Results
- Posted 29 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.
Detailed description
The primary objectives of this project are as follows:
- To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
- To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.
- To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: TMSOpen label single arm study to determine safety and effectiveness of TMS for post stroke depression |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between the ages of 22-85 years old
- Radiographic evidence of acute or subacute stroke
- Ischemic stroke diagnosed within the last 2 weeks to 6 months
- HAMD depression score 8 or greater
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- Metallic objects or neurostimulators implanted intracranially
- Stroke in the area of stimulation
- Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
- ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
- Current use of illicit substances
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 |
|---|---|---|
| TMSNeuroStar TMS Therapy | Device | TMS |
Primary outcome
Number of Participants With Adverse Events
Time frame: After Day 1 of rTMS treatment
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: After Day 2 of rTMS treatment
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: After Day 3 of rTMS treatment
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: After Day 4 of rTMS treatment
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: 3 months following neurostimulation
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: 6 months following neurostimulation
Count of Adverse Events Reported during follow up
Number of Participants With Adverse Events
Time frame: 12 months following neurostimulation
Count of Adverse Events Reported during follow up
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Time frame: Depressive symptoms will be quantified before the rTMS stimulation protocol
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Time frame: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Time frame: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Time frame: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
Time frame: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.
Depressive symptoms as rated by the Hamilton Depression Rating Scale. Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32849235Frey J, Najib U, Lilly C, Adcock A. Novel TMS for Stroke and Depression (NoTSAD): Accelerated Repetitive Transcranial Magnetic Stimulation as a Safe and Effective Treatment for Post-stroke Depression. Front Neurol. 2020 Aug 11;11:788. doi: 10.3389/fneur.2020.00788. eCollection 2020.
- 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 TMS in people with Post-stroke Depression, run by Amelia Adcock 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 6 inclusion and 7 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 29 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2022). 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?
Number of Participants With Adverse Events (time frame: After Day 1 of rTMS treatment). The study lists 12 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 NCT04093843, 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 29 Apr 2022.