Mild Cognitive ImpairmentNCT02420522
Magnetic Brain Stimulation in the Treatment of Mild Cognitive Impairment
A study testing Repetitive Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment, run by University of Manitoba at 1 site in Canada.
Trial summary
This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main objective of this study is to investigate the ability of rTMS to produce cognitive improvement in individuals with MCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Dec 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults presenting with mild cognitive impairment (trauma and non-trauma related)
Who cannot join
- History of a psychotic episode
- History of neurological illness
- Active alcohol or substance abuse
- History of seizure disorder
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Mild Cognitive Impairment Due to Brain Injury
This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main objective of this study is to investigate the ability of rTMS to produce cognitive improvement in individuals with MCI. A secondary objective is to determine whether individuals with MCI following mild brain trauma respond differently to rTMS treatment compared to individuals with non-trauma related MCI.
Participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions. Cognitive testing will include verbal, semantic, logic, visual, conceptual, and memory tasks.
Read the detailed description
This is an open-label pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). 16 patients with trauma-related MCI and 16 patients with non-trauma-related MCI will be recruited. All patients will undergo one week of active rTMS stimulation and one week of sham stimulation, separated by at least one week. Each treatment week will consist of five consecutive daily stimulation sessions. The order of active versus sham treatment sessions will be counterbalanced across subjects within each group (i.e., half of the subjects in each group will receive active stimulation first and half will receive sham first). Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions.
Additional participants (n=32; 16 without TBI) will be recruited who are receiving a full course (30 sessions) of active rTMS treatment (without a sham intervention). These participants will complete the same cognitive testing as the sham-crossover group at three time-points: pre-treatment, mid-treatment (after session 16), and post-treatment (after session 30).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Transcranial Magnetic Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
A non-invasive method of brain stimulation.
Sham Transcranial Magnetic StimulationDevice
A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
| Study group | Role | What they receive |
|---|---|---|
| Active-first | Experimental | Participants randomly assigned to this arm will receive one week of active Repetitive Transcranial Magnetic Stimulation prior to one week of Sham Transcranial Magnetic Stimulation, separated by at least one week. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation |
| Sham-first | Experimental | Participants randomly assigned to this arm will receive one week of Sham Transcranial Magnetic Stimulation prior to one week of active Repetitive Transcranial Magnetic Stimulation, separated by at least one week. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Transcranial Magnetic Stimulation |
| Full-course Active | Active comparator | Participants in this arm will receive three weeks (30 session, twice-daily) of active Repetitive Transcranial Magnetic Stimulation. This arm will not involve random assignment. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive changes
Cognitive changes will be monitored through the administration of a number of pencil-and-paper and computer-based tasks that will be performed before and after each treatment week.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2017
- Study completionDec 2021 (estimated)
Why it stopped: Low recruitment rates and timeline viability analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mandana Modirrousta, MD PhD FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420522
- Sponsor's protocol ID
- B2014:134
- Status last verified
- Sep 2021
- First submitted
- 14 Apr 2015
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Repetitive Transcranial Magnetic Stimulation in the Treatment of Mild Cognitive Impairment Due to Brain Injury
- ClinicalTrials.gov ID
- NCT02420522
- Acronym / sponsor ID
- B2014:134
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Low recruitment rates and timeline viability analysis.
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 20 Apr 2015 (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.
This is a pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). The main objective of this study is to investigate the ability of rTMS to produce cognitive improvement in individuals with MCI. A secondary objective is to determine whether individuals with MCI following mild brain trauma respond differently to rTMS treatment compared to individuals with non-trauma related MCI.
Participants will undergo both active and sham (placebo) rTMS treatment. Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions. Cognitive testing will include verbal, semantic, logic, visual, conceptual, and memory tasks.
Detailed description
This is an open-label pilot study to test the efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive improvement in individuals with mild cognitive impairment (MCI). 16 patients with trauma-related MCI and 16 patients with non-trauma-related MCI will be recruited. All patients will undergo one week of active rTMS stimulation and one week of sham stimulation, separated by at least one week. Each treatment week will consist of five consecutive daily stimulation sessions. The order of active versus sham treatment sessions will be counterbalanced across subjects within each group (i.e., half of the subjects in each group will receive active stimulation first and half will receive sham first). Cognitive and psychological assessments will be administered before and after each week of rTMS therapy, for both active and sham conditions.
Additional participants (n=32; 16 without TBI) will be recruited who are receiving a full course (30 sessions) of active rTMS treatment (without a sham intervention). These participants will complete the same cognitive testing as the sham-crossover group at three time-points: pre-treatment, mid-treatment (after session 16), and post-treatment (after session 30).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active-first | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Device: Sham Transcranial Magnetic StimulationParticipants randomly assigned to this arm will receive one week of active Repetitive Transcranial Magnetic Stimulation prior to one week of Sham Transcranial Magnetic Stimulation, separated by at least one week. |
| Sham-first | Experimental | Device: Repetitive Transcranial Magnetic Stimulation, Device: Sham Transcranial Magnetic StimulationParticipants randomly assigned to this arm will receive one week of Sham Transcranial Magnetic Stimulation prior to one week of active Repetitive Transcranial Magnetic Stimulation, separated by at least one week. |
| Full-course Active | Active comparator | Device: Repetitive Transcranial Magnetic StimulationParticipants in this arm will receive three weeks (30 session, twice-daily) of active Repetitive Transcranial Magnetic Stimulation. This arm will not involve random assignment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults presenting with mild cognitive impairment (trauma and non-trauma related)
Key exclusion criteria (5 listed)
- History of a psychotic episode
- History of neurological illness
- Active alcohol or substance abuse
- History of seizure disorder
- Currently pregnant
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 |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationA non-invasive method of brain stimulation. | Device | Active-first, Full-course Active, Sham-first |
| Sham Transcranial Magnetic StimulationA device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain. | Device | Active-first, Sham-first |
Primary outcome
Cognitive changes
Time frame: Three weeks
Cognitive changes will be monitored through the administration of a number of pencil-and-paper and computer-based tasks that will be performed before and after each treatment week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
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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.
Mandana Modirrousta, MD PhD FRCPC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Mild Cognitive Impairment, run by University of Manitoba at 1 site in Canada.
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 1 inclusion and 5 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: paused, as of the sponsor's last update on 8 Oct 2021. 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 Canada. 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?
Results are not available in the source record.
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?
Cognitive changes (time frame: Three weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2021.