Treatment and Recovery Monitoring of Post TBI Symptoms

NCT ID: NCT02426749

Last Updated: 2022-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-03-31

Brief Summary

This proposal aims to investigate the effect of a promising treatment for persistent post Traumatic Brain Injury (TBI) symptoms, and to monitor TBI patient's recovery by an objective technique along with standard clinical assessments. The treatment tool is the application of repetitive Transcranial Magnetic Stimulation (rTMS) to the dorsolateral prefrontal cortex (DLPFC) of the brain. The treatment efficacy and monitoring TBI patients' recovery will be objectively assessed using Electrovestibulography (EVestGTM); this will be in parallel with clinical and standard assessments.

Detailed Description

TBI is a significant health problem mainly because of its plausible prolonged sequelae and lack of objective measures for recovery. The conventional treatment after a TBI is physical rehabilitation that helps with motor functional recovery. However, there are usually some disabling persistent post-TBI symptoms (mostly neurological) that do not respond to the current clinical and physical rehabilitation. rTMS, on the other hand, is a promising, well-tolerated, non-invasive brain neuromodulation technique that has emerged as a therapeutic tool for a variety of neurological conditions. Thus, the researchers' aim to investigate the effect of rTMS treatment on post-TBI symptoms in patients identified by the medical collaborators (Drs. Mansouri and Salter). Equally important is to have an objective measure of treatment efficacy and patient's symptoms recovery. EVestGTM is a noninvasive technique to record neural activity from the vestibular apparatus and vestibular nuclei in the external ear. After a head injury, people commonly experience balance (vestibular) problems and dizziness, as well as confused thinking. Considering the well-known bidirectional anatomical links of the vestibular system, following an impact TBI, EVestG signals are expected to change, and our pilot studies show a great potential of EVestG to monitor the impact of TBI. Thus, the researchers aim to use EVestG as an objective measure to monitor the recovery path during and after the rTMS treatment in parallel to clinical and neuro-psychological assessments.

Conditions

Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Coil

Participants of this arm will receive active rTMS intervention (treatment).

Group Type: ACTIVE_COMPARATOR

Active repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS.

Sham

Participants of this arm will receive sham rTMS intervention (treatment).

Group Type: SHAM_COMPARATOR

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain.

Interventions

Active repetitive Transcranial Magnetic Stimulation (rTMS)

The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS.

Intervention Type: DEVICE

Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Participants must be of age 18-70 years, and have had TBI in the last 12 months prior to inclusion and presence of persistent TBI symptoms at the time of inclusion as confirmed by the co-investigator physicians.

Exclusion Criteria

1. Use of neuro- or psycho-active medications as published in recommendations

2. Active use of illicit drugs

3. History of epilepsy

4. History of any other brain lesions including tumors, infectious, vascular, or metabolic lesions

5. Severe or recent heart diseases

6. Alcoholism

7. Pregnancy

8. The presence of metallic objects in the body; dental implants are fine but people with pacemakers are to be excluded; anything that is unsafe under MRI would be considered unsafe for TMS [26].

9. Lack of ability to adequately communicate (understand, read, speak) in English and understand the experimental protocol.

10. Pending litigation (i.e., patients with pending actions regarding disability reports, litigation, or other kinds of financial compensation).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Riverview Health Center

Winnipeg, Manitoba, Canada

Countries

Canada

References

Moussavi Z, Suleiman A, Rutherford G, Ranjbar Pouya O, Dastgheib Z, Zhang W, Salter J, Wang X, Mansouri B, Lithgow B. A Pilot Randomised Double-Blind Study of the Tolerability and efficacy of repetitive Transcranial Magnetic Stimulation on Persistent Post-Concussion Syndrome. Sci Rep. 2019 Apr 2;9(1):5498. doi: 10.1038/s41598-019-41923-6.

Reference Type: DERIVED

PMID: 30940870 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

B2015:032

Identifier Type: -

Identifier Source: org_study_id