Traumatic Brain InjuryNCT01248390
"Interactive Metronome Technology for Blast-Related Traumatic Brain Injury"
A study testing Interactive metronome in people with Traumatic Brain Injury and Post-Concussion Syndrome, run by The Defense and Veterans Brain Injury Center at 1 site in United States.
Trial summary
The purpose of this research is to see whether adding a new therapy helps people with brain injury focus better and think more clearly. You are being asked to participate in this research study because you have had a brain injury. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post-Concussion Syndrome
- What is being tested?
- Interactive metronome
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 3 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Blast-related traumatic brain injury patients at least 3 months post injury with recovery to a Rancho los Amigos level 7 or 8 (alert and oriented).
- Brain injury documented by at least one of the following:
- loss of consciousness, post traumatic amnesia ii. alteration in mental status (dazed/confused), and/or physical evidence of iii.trauma (MRI/CT hemorrhage/contusion)
- A diagnosis of Postconcussional Disorder or Mild Neurocognitive Disorder Due to a General Medical Condition.
- Military or Veteran beneficiary
- Males and females aged 18-55
Who cannot join
- Current/prior (last 6 months) unstable medical condition that could affect current brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
- Status post craniectomy prior to cranioplasty (must be 90 days post cranioplasty without surgical complication)
- Prior History of moderate to severe TBI (not including present injury).
- Current (last 3 months) active suicidal or homicidal ideation or intent.
- Current (last month) drug/alcohol abuse or dependence as determined by a score of 5 or higher on the Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
- Use of benzodiazepine or narcotic medications.
- Participation in a concurrent drug or treatment trial
- Must be physically able to complete the treatment tasks (including sensory functions).
Trial locations and contacts
1 site in 1 country.
United States1 site
Warrior Recovery Center
Colorado Springs, Colorado, 80913
About this study
Official title: "A Randomized, Controlled, Trial of Interactive Metronome Technology for Remediation of Cognitive Difficulties Following Blast-Related Traumatic Brain Injury"
The purpose of this research is to see whether adding a new therapy helps people with brain injury focus better and think more clearly. You are being asked to participate in this research study because you have had a brain injury. If you decide to volunteer, you will be in the study for about six months.As a participant, you will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means you will have a chance of being assigned to either of the plans. One group will be given an experimental therapy using a metronome one hour a day, three times a week. A metronome is a device that produces a steady beat. You will need to keep time with the metronome doing several different movements. On each beat, you will be given information both through sound and on a computer screen about whether you were early or late and how far off beat you were. The tempo of the beat will be at 54 beats per minute, so you will need to process the feedback information very quickly to adjust your speed up or down to match the beat. The various movements include things like clapping hands, tapping toes, or alternating between different similar movements. It is hoped that the metronome will help subjects to concentrate better.
Read the detailed description
The design of this study will be a randomized, controlled trial of Interactive Metronome (IM) treatment compared with treatment as usual in patients with moderate to mild Traumatic Brain Injury (TBI) due to blast. The study will be conducted at the Evans Army Community Hospital at Fort Carson, Colorado . Patients will be randomized to IM training, or to a treatment as usual/wait-list control condition. Patients randomized to receive IM training will complete 15 sessions consisting of approximately 2000 repetitions each. Patients randomized to treatment as usual will be offered the opportunity to receive IM training following the conclusion of the six month study period. Outcome assessment will focus on phase lag and coherence of electroencephalogram (EEG) activity, which are electrophysiological measures of cortical connectivity. Primary outcomes will also include attention and memory functioning, which are measured prior to the start of treatment, one week following the end of treatment and 6 months after treatment ends.
Interactive Metronome (IM) technology is a behavioral feedback operant conditioning system.15 In biofeedback, physiological information is displayed to the patient but with IM information about the patient's behavioral responses is provided to them. Below the investigators provide a detailed description of the behavioral tasks and give some idea as to the program's complexity and operation. IM technology takes advantage of each of the above discussed factors related to neuroplastic processes and integrates them into a single set of tasks that are designed to encourage integrated neuroplastic activity under cognitively demanding circumstances. The computerized feedback is reliable, consistent, timely, and directly correlated with motor output. The feedback is also presented in a rich cognitive and sensory environment that combines instantaneous delivery of simultaneous auditory and visual feedback following the motor response. This information aids the preparation of the upcoming behavioral response. All of this feedback processing and adjustment of behavioral responses must occur in just over a second (1.111 seconds) because the default tempo for IM training is 54 beats per minute. This places a considerable temporal demand upon the attentional, integration, decision making, inhibitory, and motor output operators of the cortex, thereby increasing processing speed and efficiency over the course of training.
- Conditions
- Traumatic Brain Injury, Post-Concussion Syndrome
- Being tested
- Interactive metronome
- Keywords
- traumatic brain injury, post-concussion
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive metronomeBehavioural
A randomized, controlled investigation into the effects of IM training on a sample of boys with attention deficit disorder showed positive results. Compared to an active control treatment, IM training improved performance on a host of measures, including attention, motor control, language processing, reading, and parental reports of improvements in the regulation of aggressive behavior.16 It should be noted that these cognitive and behavioral functions are common symptom areas in individuals surviving TBI and are likely to be especially affected in cases of blast injury
| Study group | Role | What they receive |
|---|---|---|
| Interactive Metronome therapy | Experimental | Fifteen one-hour training sessions using Interactive Metronome system, in addition to treatment as usual. Receives: Behavioral: Interactive metronome |
| Treatment as Usual | No intervention | Standard of care symptom management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome Measure
Determine whether IM training leads to improvements in attention and memory immediately post treatment and at six months in comparison to rehabilitation treatment as usual.
Measured: Six Months Post Treatment
Secondary outcomes (1)
Outcome Measure
Determine whether the addition of Interactive Metronome training leads to better secondary outcomes such as postconcussion symptom status, vocational functioning, and quality of life at 6 months in comparison to treatment as usual.
Measured: Six Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2014
- Study completion3 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Defense and Veterans Brain Injury Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Renee M Pazdan, MD, Principal investigator, United States Public Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248390
- Sponsor's protocol ID
- A-14853.22
- Status last verified
- Jun 2017
- First submitted
- 22 Nov 2010
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nelson LA, Macdonald M, Stall C, Pazdan R. Effects of interactive metronome therapy on cognitive functioning after blast-related brain injury: a randomized controlled pilot trial. Neuropsychology. 2013 Nov;27(6):666-79. doi: 10.1037/a0034117. Epub 2013 Sep 23.
PubMed 24059443
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Randomized, Controlled, Trial of Interactive Metronome Technology for Remediation of Cognitive Difficulties Following Blast-Related Traumatic Brain Injury"
- ClinicalTrials.gov ID
- NCT01248390
- Acronym / sponsor ID
- A-14853.22
- Conditions
- Traumatic Brain Injury, Post-Concussion Syndrome
- Keywords
- traumatic brain injury, post-concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- The Defense and Veterans Brain Injury CenterUS federal agency
- Study start
- Aug 2010
- Primary completion
- May 2014 (actual)
- Study completion
- 3 Oct 2016 (actual)
- First posted
- 25 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to see whether adding a new therapy helps people with brain injury focus better and think more clearly. You are being asked to participate in this research study because you have had a brain injury. If you decide to volunteer, you will be in the study for about six months.As a participant, you will be randomly assigned to one of 2 treatment plans. Randomization is a process like flipping a coin and means you will have a chance of being assigned to either of the plans. One group will be given an experimental therapy using a metronome one hour a day, three times a week. A metronome is a device that produces a steady beat. You will need to keep time with the metronome doing several different movements. On each beat, you will be given information both through sound and on a computer screen about whether you were early or late and how far off beat you were. The tempo of the beat will be at 54 beats per minute, so you will need to process the feedback information very quickly to adjust your speed up or down to match the beat. The various movements include things like clapping hands, tapping toes, or alternating between different similar movements. It is hoped that the metronome will help subjects to concentrate better.
Detailed description
The design of this study will be a randomized, controlled trial of Interactive Metronome (IM) treatment compared with treatment as usual in patients with moderate to mild Traumatic Brain Injury (TBI) due to blast. The study will be conducted at the Evans Army Community Hospital at Fort Carson, Colorado . Patients will be randomized to IM training, or to a treatment as usual/wait-list control condition. Patients randomized to receive IM training will complete 15 sessions consisting of approximately 2000 repetitions each. Patients randomized to treatment as usual will be offered the opportunity to receive IM training following the conclusion of the six month study period. Outcome assessment will focus on phase lag and coherence of electroencephalogram (EEG) activity, which are electrophysiological measures of cortical connectivity. Primary outcomes will also include attention and memory functioning, which are measured prior to the start of treatment, one week following the end of treatment and 6 months after treatment ends.
Interactive Metronome (IM) technology is a behavioral feedback operant conditioning system.15 In biofeedback, physiological information is displayed to the patient but with IM information about the patient's behavioral responses is provided to them. Below the investigators provide a detailed description of the behavioral tasks and give some idea as to the program's complexity and operation. IM technology takes advantage of each of the above discussed factors related to neuroplastic processes and integrates them into a single set of tasks that are designed to encourage integrated neuroplastic activity under cognitively demanding circumstances. The computerized feedback is reliable, consistent, timely, and directly correlated with motor output. The feedback is also presented in a rich cognitive and sensory environment that combines instantaneous delivery of simultaneous auditory and visual feedback following the motor response. This information aids the preparation of the upcoming behavioral response. All of this feedback processing and adjustment of behavioral responses must occur in just over a second (1.111 seconds) because the default tempo for IM training is 54 beats per minute. This places a considerable temporal demand upon the attentional, integration, decision making, inhibitory, and motor output operators of the cortex, thereby increasing processing speed and efficiency over the course of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Metronome therapy | Experimental | Behavioral: Interactive metronomeFifteen one-hour training sessions using Interactive Metronome system, in addition to treatment as usual. |
| Treatment as Usual | No intervention | –Standard of care symptom management. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Blast-related traumatic brain injury patients at least 3 months post injury with recovery to a Rancho los Amigos level 7 or 8 (alert and oriented).
- Brain injury documented by at least one of the following:
- A diagnosis of Postconcussional Disorder or Mild Neurocognitive Disorder Due to a General Medical Condition.
- Military or Veteran beneficiary
- Males and females aged 18-55
Key exclusion criteria (8 listed)
- Current/prior (last 6 months) unstable medical condition that could affect current brain function (e.g. clear anoxic episode, cardiac arrest, current uncontrolled diabetes)
- Status post craniectomy prior to cranioplasty (must be 90 days post cranioplasty without surgical complication)
- Prior History of moderate to severe TBI (not including present injury).
- Current (last 3 months) active suicidal or homicidal ideation or intent.
- Current (last month) drug/alcohol abuse or dependence as determined by a score of 5 or higher on the Alcohol Use Disorders Identification Test Consumption (AUDIT-C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive metronomeA randomized, controlled investigation into the effects of IM training on a sample of boys with attention deficit disorder showed positive results. Compared to an active control treatment, IM training improved performance on a host of measures, including attention, motor control, language processing, reading, and parental reports of improvements in the regulation of aggressive behavior.16 It should be noted that these cognitive and behavioral functions are common symptom areas in individuals surviving TBI and are likely to be especially affected in cases of blast injury | Behavioural | Interactive Metronome therapy |
Primary outcome
Outcome Measure
Time frame: Six Months Post Treatment
Determine whether IM training leads to improvements in attention and memory immediately post treatment and at six months in comparison to rehabilitation treatment as usual.
1 secondary outcome
Outcome Measure
Time frame: Six Months Post Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Results publication: PubMed 24059443Nelson LA, Macdonald M, Stall C, Pazdan R. Effects of interactive metronome therapy on cognitive functioning after blast-related brain injury: a randomized controlled pilot trial. Neuropsychology. 2013 Nov;27(6):666-79. doi: 10.1037/a0034117. Epub 2013 Sep 23.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renee M Pazdan, MD principal investigator
United States Public Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive metronome in people with Traumatic Brain Injury and Post-Concussion Syndrome, run by The Defense and Veterans Brain Injury Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome Measure (time frame: Six Months Post Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01248390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2017.