N/A
N=6
TMS for Post Stroke Depression
Post-stroke Depression
Bottom Line
View on ClinicalTrials.gov: NCT04093843 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TMS (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Amelia Adcock
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Number of Participants With Adverse Events |
— | — |
| PRIMARY Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
4.667 | — |
| PRIMARY Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
4.667 | — |
| PRIMARY Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
4.667 | — |
| PRIMARY Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
4.667 | — |
| PRIMARY Depressive Symptoms as Rated by the Hamilton Depression Rating Scale |
4.667 | — |
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. This will be an open label trial and thus all participants will receive the active rTMS intervention.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04093843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.