Impact of Spaced iTBS on Plasticity in the Motor Cortex
NCT ID: NCT06735794
Last Updated: 2026-02-04
Study Results
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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COMPLETED
NA
29 participants
INTERVENTIONAL
2024-11-13
2026-02-01
Brief Summary
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This trial will compare the effects of the compressed iTBS (iTBS-c) protocol, which is commonly used to treat depression, and the spaced iTBS (iTBS-s) protocol. Researchers want to find out which protocol is better able to produce changes in brain plasticity. Sham iTBS (iTBS-sh) will be used as a control to make the results of the study more reliable.
Participants will complete 5 study visits within the span of 3 months, including:
* Screening assessments to determine eligibility (Visit 1);
* Calibration iTBS session (Visit 2) to assess tolerability of brain stimulation;
* Three experimental iTBS sessions (iTBS-s, iTBS-c, and iTBS-sh) in a randomized order (Visits 3-5), each separated by at least 72 hours. During each session, the study team will stimulate the motor cortex and record the muscle activity of your hand to measure changes in brain plasticity.
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Detailed Description
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Neuroimaging techniques have implicated the dysregulation of brain plasticity in depression. In particular, long-term potentiation (LTP)-like activity in the dorsolateral prefrontal cortex (DLPFC) and the motor cortex is known to be impaired in MDD. As such, transcranial magnetic stimulation (TMS)-based interventions, which aim to modify underlying cortical activity, are now established treatments of depression. Intermittent theta-burst stimulation (iTBS), a novel form of repetitive TMS approved by the US Food and Drug Administration (FDA) for the treatment of depression, delivers intermittent, high-frequency theta bursts. It has been demonstrated to induce sustained plasticity in the DLPFC and the motor cortex. Although iTBS is approved for the treatment of depression, response and remission rates for MDD are still relatively low.
Based on promising research conducted in the hippocampus of rodents, the investigators believe that modifying some parameters of the iTBS protocol may be more effective in inducing plasticity than the currently used iTBS protocol. Thus, in this trial researchers aim to optimize iTBS and its effects on cortical plasticity as a first step towards optimizing it for the treatment of depression.
The primary and secondary objectives and hypotheses of the study are as follows:
Objective 1: To compare the effect of compressed iTBS (iTBS-c) to spaced iTBS (iTBS-s) on LTP-like activity (referred to hereafter as iTBS-LTP) as measured using motor evoked potentials (MEPs) recorded from the right abductor pollicis brevis (APB), abductor digiti minimi (ADM), and first dorsal interosseous (FDI) muscles.
Hypothesis 1: iTBS-s will elicit larger iTBS-LTP post-iTBS as compared to iTBS-c.
Objective 2: To compare the effect of iTBS-c and iTBS-s on iTBS-LTP relative to iTBS-sh.
Hypothesis 2: iTBS-c and iTBS-s will elicit larger iTBS-LTP post-iTBS as compared to iTBS-sh.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Compressed iTBS
After completing Visits 1-2 (Screening and Calibration), participants will undergo the iTBS-c condition in a randomized order during Visits 3 to 5. iTBS-c is the active comparator.
Compressed iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-c (active comparator), which will be delivered unilaterally to the left motor cortex. Following iTBS-c, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Spaced iTBS
After completing Visits 1-2 (Screening and Calibration), participants will undergo the iTBS-s condition in a randomized order during Visits 3 to 5. iTBS-s is the experimental study intervention.
Spaced iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-s (experimental study intervention), which will be delivered unilaterally to the left motor cortex. Following iTBS-s, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Sham iTBS
After completing Visits 1-2 (Screening and Calibration), participants will undergo the iTBS-sh condition in a randomized order during Visits 3 to 5. iTBS-sh is the sham comparator.
Sham iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-sh (sham comparator), which will be delivered unilaterally to the left motor cortex. Following iTBS-sh, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Interventions
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Compressed iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-c (active comparator), which will be delivered unilaterally to the left motor cortex. Following iTBS-c, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Spaced iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-s (experimental study intervention), which will be delivered unilaterally to the left motor cortex. Following iTBS-s, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Sham iTBS
Intermittent Theta-Burst Stimulation (iTBS) is a form of non-invasive brain stimulation that uses magnetic pulses applied to the scalp using a coil. iTBS will be used to stimulate the left motor cortex to enhance long-term potentiation (LTP)-like activity, a physiological mechanism associated with brain plasticity.
During the intervention, the study team will conduct two pre-iTBS TMS measurements (Pre-30 and Pre-15). Participants will then complete iTBS-sh (sham comparator), which will be delivered unilaterally to the left motor cortex. Following iTBS-sh, five post-iTBS TMS measurements (Post-0, 15, 30, 45, and 60) will be obtained. Motor evoked potentials (MEPs) will be recorded from the right APB, ADM, and FDI muscles to assess the effects of the stimulation.
The MCF-B65, MCF-P-B65, and/or Cool-B65 A/P TMS coils will be used, alongside the MagPro R30 or the MagPro X100 TMS stimulators to deliver the intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Right handedness, assessed using the Edinburgh Handedness Inventory (EHI).
3. Sufficiently proficient in English to complete the required study assessments, as per investigator judgement.
4. Willingness and capacity to provide informed consent.
5. Willingness to comply with all study procedures.
Exclusion Criteria
2. Current use of any psychotropic medications (e.g. anti-depressants, anti-convulsants, anti-psychotics, etc.).
3. Contraindications to transcranial magnetic stimulation (TMS), as per investigator judgment.
4. Lifetime history of any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis, assessed using the Structured Clinical Interview for DSM-5 (SCID-5), except simple phobias.
5. Left handed or ambidextrous, assessed using the EHI, to minimize the heterogeneity in cortical excitability and plasticity.
6. Self-reported history of seizures and/or other major neurological conditions, as per investigator judgement, due to the risk of seizures associated with TMS in individuals with a heightened risk.
18 Years
50 Years
ALL
Yes
Sponsors
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Centre for Addiction and Mental Health
OTHER
Responsible Party
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Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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References
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Berlim MT, McGirr A, Rodrigues Dos Santos N, Tremblay S, Martins R. Efficacy of theta burst stimulation (TBS) for major depression: An exploratory meta-analysis of randomized and sham-controlled trials. J Psychiatr Res. 2017 Jul;90:102-109. doi: 10.1016/j.jpsychires.2017.02.015. Epub 2017 Feb 21.
Chung SW, Hoy KE, Fitzgerald PB. Theta-burst stimulation: a new form of TMS treatment for depression? Depress Anxiety. 2015 Mar;32(3):182-92. doi: 10.1002/da.22335. Epub 2014 Nov 28.
Höflich G, Kasper S, Hufnagel A, Ruhrmann S, Möller HJ. Application of transcranial magnetic stimulation in treatment of drug-resistant major depression-a report of two cases. Human Psychopharmacology: Clinical and Experimental. 1993;8(5):361-365.
George MS, Wassermann EM, Williams WA, Callahan A, Ketter TA, Basser P, Hallett M, Post RM. Daily repetitive transcranial magnetic stimulation (rTMS) improves mood in depression. Neuroreport. 1995 Oct 2;6(14):1853-6. doi: 10.1097/00001756-199510020-00008.
George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
Cantone M, Bramanti A, Lanza G, Pennisi M, Bramanti P, Pennisi G, Bella R. Cortical Plasticity in Depression. ASN Neuro. 2017 May-Jun;9(3):1759091417711512. doi: 10.1177/1759091417711512.
Vignaud P, Damasceno C, Poulet E, Brunelin J. Impaired Modulation of Corticospinal Excitability in Drug-Free Patients With Major Depressive Disorder: A Theta-Burst Stimulation Study. Front Hum Neurosci. 2019 Feb 26;13:72. doi: 10.3389/fnhum.2019.00072. eCollection 2019.
Liu W, Ge T, Leng Y, Pan Z, Fan J, Yang W, Cui R. The Role of Neural Plasticity in Depression: From Hippocampus to Prefrontal Cortex. Neural Plast. 2017;2017:6871089. doi: 10.1155/2017/6871089. Epub 2017 Jan 26.
Duman RS. Pathophysiology of depression: the concept of synaptic plasticity. Eur Psychiatry. 2002 Jul;17 Suppl 3:306-10. doi: 10.1016/s0924-9338(02)00654-5.
Other Identifiers
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2023/218
Identifier Type: -
Identifier Source: org_study_id
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