Combined Transcranial Magnetic Stimulation and Cognitive Treatment in Blast Traumatic Brain Injury

NCT ID: NCT01596569

Last Updated: 2018-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-11-18

Brief Summary

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This study investigates the efficacy of a novel neurorehabilitation program combining noninvasive brain stimulation (transcranial magnetic stimulation or TMS) and cognitive therapy, on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

Detailed Description

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The most common blast-induced traumatic brain injury (bTBI)-associated problems are cognitive deficits, such as executive functioning and memory. This study evaluates a combined rehabilitation program: transcranial magnetic stimulation (TMS) and cognitive therapy for treatment of patients with bTBI. TMS is a noninvasive way of stimulating the brain, which is not painful and does not involve any needles or any form of surgery. It acts by delivering a magnetic stimulation to a particular brain region. Half of the study participants will receive cognitive intervention with active TMS, and a control group will receive cognitive intervention with sham TMS. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System and Beth Israel Deaconess Medical Center.

Conditions

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Traumatic Brain Injury Cognitive Dysfunction Blast Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active TMS and Cognitive Intervention

Active TMS and Cognitive Intervention:

Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.

Cognitive Intervention

Intervention Type BEHAVIORAL

Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.

All participants receive weekly cognitive treatment sessions for 10 weeks.

Sham TMS and Cognitive Intervention:

Sham TMS and Cognitive Intervention:

Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory).

Group Type SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type DEVICE

Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.

Cognitive Intervention

Intervention Type BEHAVIORAL

Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.

All participants receive weekly cognitive treatment sessions for 10 weeks.

Interventions

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Repetitive Transcranial Magnetic Stimulation (rTMS)

Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.

Intervention Type DEVICE

Cognitive Intervention

Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.

All participants receive weekly cognitive treatment sessions for 10 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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Transcranial Magnetic Stimulation Noninvasive Brain Stimulation Magstim Corporation Cognitive Rehabilitation Cognitive Training

Eligibility Criteria

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Inclusion Criteria

* OEF/OIF active-duty personnel or veterans exposed to blast
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-50
* Primary language is English

Exclusion Criteria

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to the blast exposure
* Hearing or vision impairment
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role collaborator

Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yelena Bogdanova, PhD

BUMC Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yelena Bogdanova, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Bogdanova Y, Verfaellie M. Cognitive sequelae of blast-induced traumatic brain injury: recovery and rehabilitation. Neuropsychol Rev. 2012 Mar;22(1):4-20. doi: 10.1007/s11065-012-9192-3. Epub 2012 Feb 17.

Reference Type BACKGROUND
PMID: 22350691 (View on PubMed)

Other Identifiers

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UL1RR025771

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-29706

Identifier Type: -

Identifier Source: org_study_id

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