TMS for Post Stroke Depression

Amelia Adcock

Status: Completed

Conditions: Post-stroke Depression

Treatments: Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04093843

1804090922

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

TMS

Experimental group

Description:

Open label single arm study to determine safety and effectiveness of TMS for post stroke depression

Treatment:

Device: TMS