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Electroconvulsive Therapy in Severe Agitation in Alzheimer's Dementia

Overview

Información sobre este estudio

McLean hospital,  Mayo Clinic,  Emory University, LIJ/Northwell, and Pine Rest Mental Health are conducting a research study using Electroconvulsive therapy (ECT)  to treat agitation in dementia. ECT is a treatment done under general anesthesia, in which brief electric currents are passed through the brain to trigger a brief seizure. It is a safe and highly effective treatment for depression.

 

Agitation is common in nearly 60% of patients with dementia, increases caretaker burden, creates safety risk for individuals with dementia and others and increases risk for hospitalization and nursing home placement.

 

While ECT is not widely used for the treatment of agitation in patients with dementia, several publications have demonstrated its ability to help for these problematic behaviors that can accompany dementia. We propose to address this critical need for a new intervention to treat severe agitation in dementia by conducting a single blind, randomized controlled trial of electroconvulsive therapy (ECT).

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Diagnosis of Alzheimer’s Dementia according to NIA-AA Criteria for dementia.
  • MMSE ≤ 15.
  • Cohen-Mansfield Agitation Inventory Nursing Home Version (CMAI) score of >5 on at least one item of aggression or a physical nonaggressive item that holds potentially dangerous consequences including hitting (including self), kicking, grabbing onto people, pushing, throwing things, biting, scratching, spitting, hurting self or other, tearing things or destroying property, making physical sexual advances, trying to get to a different place, intentional falling, screaming, making verbal sexual advances, and cursing or verbal aggression (items 1-11, 14, 15, 22-24).
  • At least three failed pharmacological interventions from different drug classes (including antidepressants, antipsychotics, anticonvulsants, prazosin, and cannabinoids) at therapeutic doses (to be determined by clinical judgment) and duration of at least two weeks each to manage behavioral symptoms. These interventions may also include medications discontinued after 1 week due to tolerability concerns. Furthermore, medication trials that occur prior to admission to the hospital may count towards the three failed trials. The trials can be inpatient and/or outpatient. These trials can also be concurrent, such as using two medications from different classes for at least one week  at the same time (i.e., polypharmacy).
  • Medically stable for safe administration of ECT verified by standard physical examination, urinalysis and serum chemistries.
  • Comprehension of English language.
  • Authorized legal representative able and willing to give informed consent.
  • Age 55 - 89 years old (inclusive).

Exclusion Criteria:

  • Current diagnosis of co-morbid delirium, measured by the Confusion Assessment Method (CAM) and by clinical diagnosis.
  • Diagnosis of Non-AD Dementia.
  • Lifetime or current diagnosis of Schizophrenia, Bipolar Disorder or Schizoaffective Disorder.
  • Active substance use disorder within past 6 months.
  • Treatment with ECT or other neurostimulation therapies (e.g., TMS or vagal nerve stimulation) within the past 3 months.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Maria Lapid, M.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Monica Walton CCRP

(507) 422-0689

Walton.Monica@mayo.edu

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20508007

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