Efficacy of Repetitive Transcranial Magnetic Stimulation for Improvement of Memory in Older Adults With TBI

NCT03727737 | Completed DMC FDA Device

• 1 other identifier: ADA0007AGG
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will evaluate the safety, durability and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non-invasive therapeutic treatment for improving memory in older adults with mild or moderate Traumatic Brain Injury (TBI) who have been experiencing residual memory or cognitive problems that affect daily functioning.

Conditions

Brain Injuries, Traumatic; Repetitive Transcranial Magnetic Stimulation; Memory Deficits; Aging

Keywords

repetitive Transcranial Magnetic Stimulation; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• CANTAB Paired Associates Learning (PAL)

  Test for visual memory and new learning: it is a hippocampal-mediated paired associates learning task. This test has twenty-one outcome measures, covering the errors made by the participant, the number of trials required to locate the pattern(s) correctly, memory scores and stages completed (Administration time 10 minutes). The main score provided is the sum of pairs reproduced over three trials (range: 0-30). We will use the average number of trials needed to succeed on PAL task as the main outcome measure.

  2-4 weeks

Secondary Outcomes (1)

• Functional Connectivity Changes in the Brain

  2-4 weeks

Other Outcomes (2)

• Quality of Life measure: Short Form of Veterans Rand 36 Item Health Survey (SF/VR-36)

  2-4 weeks

• Sustained Improvement in primary Outcome Measure (CANTAB Paired Associates Learning (PAL)) at 6 months post-treatment

  6 months

Study Arms (2)

Sham

NO INTERVENTION

Patients with mild and moderate TBI will be assigned randomly to this arm and will not receive treatment

ACTIVE

ACTIVE COMPARATOR

Patients with mild and moderate TBI will be assigned randomly to this arm and will receive treatment

Device: Repetitive Transcranial magnetic Stimulation

Interventions

Repetitive Transcranial magnetic Stimulation DEVICE

RTMS will be delivered via magventure machine, on an approved FDA IDE protocol to DLPFC region to improve memory in older adults (veterans and non-veterans) with mild and moderate TBI.

Also known as: rTMS

ACTIVE

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-75 years, with a high school education
• History of mild or moderate TBI as defined by the DoD/VA Clinical Practice Guidelines for Definition of TBI
• Ability to obtain a Motor Threshold (MT) will be determined during the screening process
• Must be in the chronic stable phase of recovery (\>6 months post injury) with residual cognitive difficulties that are affecting daily functioning (including self-reported memory or cognition problems)
• If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and patient will be willing to remain on a stable regimen during the acute treatment phase
• Has an adequately stable condition and environment to enable attendance at scheduled clinic visits
• For female participants of child bearing potential, agrees to use one of the following acceptable methods of birth control: abstinence, oral contraceptive, Norplant, Depo-Provera, a condom with spermicide, a cervical cap with spermicide, a diaphragm with spermicide, an intrauterine device, surgical sterilization (having your tubes tied)
• Able to read, verbalize understanding, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments
• Individuals who meet the study criteria but have impaired decision making capacity may participate provided they are able to voluntarily sign an Assent Form and have an LAR who can sign a Consent Form and accompany the participant to all study visits

You may not qualify if:

• Diagnosed with Dementia
• Pregnant or lactating female.
• Unable to be safely withdrawn, at least two-weeks prior to beginning treatment, from medications that substantially increase the risk of seizures
• Have a cardiac pacemaker or a cochlear implant
• Have a mass lesion, cerebral infarct or other active CNS disease, including a seizure disorder
• Known current psychosis as determined by DSM-IV coding in chart (Axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder
• Diagnosis of Bipolar Affective Disorder I (as determined by chart review and intake interview), since this in conjunction with TBI increases seizure risk
• Current amnesic disorders, dementia, MOCA ≤ 16, or delirium.
• Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via AUDIT, within 3 months prior to screening
• Prior history of seizures
• Severe TBI or open head injury
• TBI within last 6 months
• Participation in another concurrent clinical trial
• Patients with prior exposure to rTMS (NOTE: TMS is allowed) or ECT
• Active current suicidal intent or plan. Patients at risk for suicide will be required to establish a written safety plan involving their primary psychiatrist. All patients at risk for suicide will be excluded from the study (as per FDA recommendation).

Sponsors & Collaborators

• Palo Alto Veterans Institute for Research: lead
• Stanford University: collaborator
• The Defense and Veterans Brain Injury Center: collaborator

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Memory Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind study until trial is complete
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientific Research Director, Defense and Veterans Brain Injury Center (DVBIC)

Model Details: The proposed study will evaluate the safety, durability and efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) as a promising non-invasive therapeutic treatment for improving memory in older adults with mild or moderate Traumatic Brain Injury (TBI) who have been experiencing residual memory or cognitive problems that affect daily functioning.

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: November 1, 2018
• Study Start: October 23, 2018
• Primary Completion: September 14, 2022
• Study Completion: September 14, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

US (1)