Treatment of Depression Post-SCI

Официальное название

Treatment of Depression Post-SCI: Retrospective Analysis and Feasibility Trial

Обзор

Depression is more common after a spinal cord injury (SCI) than in the general population. Unfortunately, it is unknown how depression is typically treated in individuals with SCI or if commonly used treatment methods are effective. This study will investigate the safety and impact of a novel method for treating depression called repetitive transcranial magnetic stimulation (rTMS). rTMS is a type of non-invasive brain stimulation. Fourteen individuals with a cervical or thoracic level SCI and depression will complete an approved treatment plan using rTMS. Participants will be treated using rTMS five days a week for four weeks. After four weeks of treatment, the study team will review the safety of rTMS and assess changes in depressive symptoms. If the results are positive, larger studies can be designed to develop better treatment options for individuals with SCI and depression.

Вмешательства

• Устройство rTMS
  The study team will deliver rTMS five days a week for four weeks, according to a specific and approved protocol for participant positioning, motor threshold determination, and dosing.

Первичные конечные точки

• Safety as assessed by number of adverse events [Срок оценки: Through the study period (5 weeks)]
• Number of visits missed [Срок оценки: Throughout the treatment period (4 weeks)]
• Change in depressive symptoms as assessed by the Hamilton Rating Scale for Depression [Срок оценки: Baseline, midpoint (Week 3), and post treatment (5 weeks)]

Вторичные конечные точки (7)

• Change in depressive symptoms as assessed by the Montgomery- Asberg Depression Rating Scale (MADRS) [Срок оценки: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
• Change in the impact depressive symptoms have on one's life as assessed by the Sheehan Disability Scale. [Срок оценки: Baseline, midpoint (Week 3), and post treatment (5 weeks)]
• Change in subjective well-being based on the Satisfaction With Life Scale. [Срок оценки: Baseline and post treatment (5 weeks)]
• Change in physical activity based on the Leisure Time Physical Activity Questionnaire for People with Spinal Cord Injury [Срок оценки: Baseline and post treatment (5 weeks)]
• Change in function as assessed by the Spinal Cord Independence Measure III-Self Report. [Срок оценки: Baseline and post treatment (5 weeks)]
• Change in function and daily activities as assessed by the Craig Handicap Assessment and Reporting Tool-Short Form [Срок оценки: Baseline and post treatment (5 weeks)]
• Change depressive symptoms as assessed by the Patient Health Questionnaire-9 score [Срок оценки: Baseline, midpoint (Week 3), and post treatment (5 weeks)]

Критерии участия

Критерии включения

• Age 18 - 70;
• At least 6 months post incomplete cervical or incomplete or complete thoracic level SCI;
• Have at least partial active movement of the right thumb (abductor pollicis brevis) to allow for FDA approved rTMS dosing;
• Major depressive disorder, as identified through screening tools;
• No antidepressant medications or no change in doses of psychotropic medication(s) for at least 4 weeks prior to the study (6 weeks if newly initiated medication).

Критерии исключения

• Concomitant neurologic diseases/disorders or dementia;
• Cognitive impairment, as identified through a screening tool (Montreal Cognitive Assessment);
• History of major head trauma as identified through a screening tool (Ohio State University Traumatic Brain Injury Identification Method);
• History of psychosis or other Axis I disorder that is primary;
• Positive screen for bipolar disorder, as identified through a screening tool (The Mood Disorder Questionnaire);
• Life expectancy <1 year;
• Attempt of suicide in the last 2 years;
• Electronic or metallic implants (i.e. metal in the head, cochlear implant, or pacemaker);
• History of seizures or currently prescribed anti-seizure medications;
• Taking medication that increases the risk of seizures;
• Pregnancy as identified through a positive pregnancy test;
• Inability or unwillingness of subject or legal guardian/representative to give informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT04263285 · 00086228

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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