Treatment and Recovery Monitoring of Post TBI Symptoms

NCT02426749 | Completed Results

• 1 other identifier: B2015:032
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in RPQ Score at Post-treatment Sessions

  RPQ is the Rivermead Post Concussion Symptoms Questionnaire. Scale ranges from 0 to 64 points, with higher scores representing a greater number or severity of reported symptoms.

  Immediately following treatment (4 weeks after baseline)

• Change From Baseline in EVestG Field Potential's Features at Post Treatment Sessions

  EVestG is the Electrovestibulography assessment, in which features of the neural field potential are extracted. The measurement here is a calculation of the area under the AP curve. The area is a product of the number of samples (1 / 41667 s each) and the normalized voltage (normalized so the field potential peak has a magnitude of 1). The result is summed over all detected field potentials. Due to the normalization, in a practical sense this value gives a metric of how wide or narrow the calculated field potential shape is.

  Immediately following treatment (4 weeks after baseline)

Secondary Outcomes (2)

• Change From Baseline in MoCA Score at Post-treatment Sessions.

  Immediately following treatment (4 weeks after baseline)

• Change From Baseline in MADRS Score at Post-treatment Sessions

  Immediately following treatment (4 weeks after baseline)

Study Arms (2)

Active Coil

ACTIVE COMPARATOR

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

Device: Active repetitive Transcranial Magnetic Stimulation (rTMS)

Sham

SHAM COMPARATOR

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

Device: Sham repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Active repetitive Transcranial Magnetic Stimulation (rTMS) 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.

Active Coil

Sham repetitive Transcranial Magnetic Stimulation (rTMS) 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.

Sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Use of neuro- or psycho-active medications as published in recommendations
• Active use of illicit drugs
• History of epilepsy
• History of any other brain lesions including tumors, infectious, vascular, or metabolic lesions
• Severe or recent heart diseases
• Alcoholism
• Pregnancy
• 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 \[26\].
• Lack of ability to adequately communicate (understand, read, speak) in English and understand the experimental protocol.
• Pending litigation (i.e., patients with pending actions regarding disability reports, litigation, or other kinds of financial compensation).

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Riverview Health Center

Winnipeg, Manitoba, R3L2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 30940870 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr Zahra Moussavi
• Organization: University of Manitoba

Zahra.Moussavi@umanitoba.ca

204 474 7023

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 27, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 14, 2022
• Results First Posted: January 18, 2020

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)