Clinical trial NCT04093843: TMS for Post Stroke Depression
Official title: Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-stroke Depression
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 6
Sex: ALL
Minimum age (years): 22
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objectives of this project are as follows:

1. To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
2. 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.
3. 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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: After Day 1 of rTMS treatment
measure: Number of Participants With Adverse Events
timeFrame: After Day 2 of rTMS treatment
measure: Number of Participants With Adverse Events
timeFrame: After Day 3 of rTMS treatment
measure: Number of Participants With Adverse Events
timeFrame: After Day 4 of rTMS treatment
measure: Number of Participants With Adverse Events
timeFrame: 3 months following neurostimulation
measure: Number of Participants With Adverse Events
timeFrame: 6 months following neurostimulation
measure: Number of Participants With Adverse Events
timeFrame: 12 months following neurostimulation
measure: Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
timeFrame: Depressive symptoms will be quantified before the rTMS stimulation protocol
measure: Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
timeFrame: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation.
measure: Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
timeFrame: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol.
measure: Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
timeFrame: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol.
measure: Depressive Symptoms as Rated by the Hamilton Depression Rating Scale
timeFrame: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol.
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
References:
citation: 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.