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rTMS for Cognitive Rehabilitation After TBI

Primary Purpose

Cognitive Impairment, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cognitive Impairment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. one or more mild to moderate TBIs*;
  2. at least one year but no more than 20 years from worst injury;
  3. ability to complete cognitive and neurophysiological testing;
  4. available for duration of study;
  5. between 18 and 65 years of age;
  6. mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale

Exclusion Criteria:

  1. severe or penetrating TBI;
  2. history of psychotic or manic illness;
  3. history of intracranial surgery;
  4. history of skull fracture;
  5. history of seizures in candidate or candidate's family
  6. ferrous metallic implants or implantable medical device;
  7. medications that are known to reduce seizure threshold;
  8. pregnancy.
  9. history of multiple sclerosis, stroke, brain tumor, epilepsy

Sites / Locations

  • Hunter Holmes McGuire Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active TMS

Sham TMS

Arm Description

Subjects receive rTMS over the right DLPFC, in 2 second bursts at 10 Hz, followed by a 19 second break, for a total of 20 minutes. Stimulator intensity is set to 80% of motor threshold on day one, and 100% of motor threshold for the remainder of intervention. This paradigm is continued for 5 consecutive days.

Identical to active arm, but stimulator intensity is reduced to 30% of motor threshold, and the stimulator coil is oriented tangentially to the skull to "stimulate" air space above the head instead of cortical tissue.

Outcomes

Primary Outcome Measures

Auditory target detection task
subjects listen to a series of sounds, and will monitor for a specific sounds.
Ruffs 2 and 7 selective attention test
subjects must visually search for the numbers 2 and 7 among other distractors.
DKEFS Verbal Fluency
a measure of internal search and selection process, requires subject to generate several lists of items.
California Verbal Learning Test II
subjects are required to learn and recall an unfamiliar word list.

Secondary Outcome Measures

EEG
resting state power spectra of EEG will be collected to analyze.

Full Information

First Posted
August 20, 2018
Last Updated
February 8, 2021
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Virginia Commonwealth Neurotrauma Initiative
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1. Study Identification

Unique Protocol Identification Number
NCT03642158
Brief Title
rTMS for Cognitive Rehabilitation After TBI
Official Title
Targeted Transcranial Magnetic Stimulation for Cognitive Rehabilitation After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Virginia Commonwealth Neurotrauma Initiative

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A novel and promising therapy for cognitive dysfunction is non-invasive brain stimulation, of which transcranial magnetic stimulation (TMS) is a form. TMS is currently FDA-approved for use in depression and migraine. It is under investigation for use in a number of other neurologic and psychiatric disorders. In addition to its potential to improve affective symptoms, recent research has suggested that TMS targeted to select cortical regions can also improve cognition. In trials of TMS therapy for psychiatric disorders, several studies have shown benefits for cognitive function alongside symptom amelioration. In healthy persons, a course of stimulation of the parietal area improved objective measures of learning and memory. Among persons with TBI, there have been case reports supporting improvement in cognitive function and postconcussive symptoms; however, there have not yet been any controlled studies of TMS for TBI-related cognitive dysfunction.
Detailed Description
Subjects with a history of TBI will be recruited into this double-blind, sham controlled, crossover with washout study design. Study will involve one week (5 consecutive days) of treatment, a 7 day off period, followed by a second week of rTMS treatment. Motor threshold will determine level of stimulation, and active rTMS stimulation will occur of the right DLPFC. Subjects will be paid for their time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Traumatic Brain Injury

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
double blinded
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TMS
Arm Type
Active Comparator
Arm Description
Subjects receive rTMS over the right DLPFC, in 2 second bursts at 10 Hz, followed by a 19 second break, for a total of 20 minutes. Stimulator intensity is set to 80% of motor threshold on day one, and 100% of motor threshold for the remainder of intervention. This paradigm is continued for 5 consecutive days.
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
Identical to active arm, but stimulator intensity is reduced to 30% of motor threshold, and the stimulator coil is oriented tangentially to the skull to "stimulate" air space above the head instead of cortical tissue.
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Intervention Description
repetitive Transcranial Magnetic Stimulation (rTMS) utilizes a magnetic coil of wire to non-invasively and painlessly activate small sections of the brain through the skull.
Primary Outcome Measure Information:
Title
Auditory target detection task
Description
subjects listen to a series of sounds, and will monitor for a specific sounds.
Time Frame
10 minutes
Title
Ruffs 2 and 7 selective attention test
Description
subjects must visually search for the numbers 2 and 7 among other distractors.
Time Frame
~5 minutes
Title
DKEFS Verbal Fluency
Description
a measure of internal search and selection process, requires subject to generate several lists of items.
Time Frame
10 minutes
Title
California Verbal Learning Test II
Description
subjects are required to learn and recall an unfamiliar word list.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
EEG
Description
resting state power spectra of EEG will be collected to analyze.
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: one or more mild to moderate TBIs*; at least one year but no more than 20 years from worst injury; ability to complete cognitive and neurophysiological testing; available for duration of study; between 18 and 65 years of age; mild or greater cognitive symptoms on the TBI-QOL Cognition General Concerns scale Exclusion Criteria: severe or penetrating TBI; history of psychotic or manic illness; history of intracranial surgery; history of skull fracture; history of seizures in candidate or candidate's family ferrous metallic implants or implantable medical device; medications that are known to reduce seizure threshold; pregnancy. history of multiple sclerosis, stroke, brain tumor, epilepsy
Facility Information:
Facility Name
Hunter Holmes McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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rTMS for Cognitive Rehabilitation After TBI

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