Motor ActivityPhase 2NCT05081986
Repeated iTBS Cycloserine Motor Plasticity
A Phase 2 study testing Transcranial Magnetic Stimulation and Cycloserine in people with Motor Activity, run by University of Calgary at 1 site in Canada.
Trial summary
Repetitive transcranial magnetic stimulation (rTMS) is a modality for probing and altering brain function in humans non-invasively. The technology relies on the principles of electromagnetic induction, whereby magnetic fields have an associated electrical field. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Transcranial Magnetic Stimulation and Cycloserine
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Aug 2021to 23 Feb 2022
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy (absence of chronic medical conditions) individuals
- Aged 18-65. The lower limit is justified by the absence of safety studies involving DCS in pediatric studies, and the upper limit is justified by the increasing prevalence of chronic illness.
Who cannot join
- Allergy to cycloserine
- Are currently pregnant, breast feeding or plan to become pregnant
- Have an alcohol or substance use disorder within the last 3 months
- Current psychiatric concerns
- are at a significant risk of harm to themselves or others
- Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of epilepsy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than or equal to 5 minutes
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- Have concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
- Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
- Conditions that may impair the ability to metabolize cycloserine including, but not limited to current Renal or Liver Disease.
- Inability to refrain from alcohol use for 24 hours prior to each session and following each session.
- Use of isoniazid or ethionamide
- Are currently (or in the last 4 weeks) using any benzodiazepine, cyclopyrrolone, gabapentin/pregabalin or anticonvulsant due to the potential to limit rTMS efficacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Plasticity Enhancement of Spaced iTBS Trains: a Randomized, Placebo-controlled, Crossover Trial of D-cycloserine.
Repetitive transcranial magnetic stimulation (rTMS) is a modality for probing and altering brain function in humans non-invasively. The technology relies on the principles of electromagnetic induction, whereby magnetic fields have an associated electrical field. By intersecting two magnetic fields safely generated outside the head, one can induce a focal electrical current where the magnetic fields intersect in the brain, and this can depolarize cell membranes and impact brain activity.
A well investigated phenomenon in neuroscience is the principle of long term potentiation (LTP), and its converse long term depression (LTD), referring to the ability of neurons to increase or decrease their connection strength in an activity dependent manner. They do this through modifications to their electrochemical junctions, the synapses. We have previously used the motor system as a model system to study the impact D-Cycloserine, an NMDA receptor partial agonist, on synaptic plasticity after TMS.
Read more
Conventional therapeutic TMS is delivered once daily, however it is increasingly being delivered multiple times per day in an effort to speed treatment effects. It is unclear how adjunctive agents would impact these repeated stimulation designs.
Research Question:
Does the N-methyl-D-aspartate receptor partial agonist D-Cycloserine stabilize motor plasticity across multiple daily sessions of TMS?
Read the detailed description
Objectives:
- To recruit 20 participants into a cross-over trial. These participants will complete two study phases (active and placebo), and will not know whether they are taking a low-dose d-cycloserine capsule (100mg) or a placebo capsule at each of these phases.
- To measure motor evoked potentials (MEP) in the hand in relation to magnetic stimulation of the motor cortex responsible for this muscle. These will be measured at baseline, and after receiving rTMS over the motor cortex.
- To deliver intermittent theta-burst rTMS stimulation (TBS) to the FDI region of the motor cortex.
- To measure the magnitude (and associated change from baseline) of the MEPs after rTMS at a fixed stimulus intensity, and using a range of stimuli to generate a stimulus response curve.
- To repeat iTBS one hour later and measure the impact on MEPs.
- To measure changes in performance on computerized cognitive tasks following ingestion of the blinded capsule.
Methods:
D-Cycloserine will be purchased from Parsolex and repackaged into 100mg placebo-controlled capsules by Script Pharmacy in Calgary.
- We will recruit 20 participants aged 18-65 through community advertisement, carefully screened for exclusion factors related to rTMS and DCS.
- Participants will be randomly assigned by random number sequence with allocation concealment to one of two first arms of the crossover study: a) placebo-DCS 100mg and b) DCS 100mg-placebo.
- Participants will complete the QIDS-SR (Quick Inventory of Depressive Symptoms-Self Report), the BAI (Beck Anxiety Inventory), and the STAI (State Trait Anxiety Inventory).
- Participants will take their blinded capsule at least 1 hour prior to TBS. (we anticipate that it will take approximately 30 minutes to do steps 5-7)
- Electromyographic (EMG) electrodes will be positioned over the first dorsal interosseous (FDI) bilaterally. These are non-invasive electrodes that use an adhesive to stick to the skin.
- Using neuronavigation in conjunction with an atlas brain, the M1 hand strip will be localized using single pulse TMS (MagPro X100).
- Motor evoked potentials are measurements of muscle activation, in this case in response to TMS stimulation of the brain. We will use single pulse TMS to record the magnitude of responses. As a baseline, we will collect twenty single-pulse (120% resting motor threshold (RMT), 0.25Hz) MEPs every 5 minutes for the 15 minutes preceding TBS rTMS. We will also characterize the stimulus response curve at baseline by delivering single pulse TMS at stimulus intensities ranging from 100-150% resting motor threshold presented in random order.
- TBS rTMS will be applied to the FDI 'hotspot'. TBS consists of 2s trains every 10s. Trains are composed of 3 pulses at 50Hz, 200ms intervals, 80% RMT. Total time 190s and 600 pulses.
- After TBS, twenty MEPs will be acquired (single pulse, 120% RMT, 0.25Hz) every 5 minutes for the first 15 minutes after iTBS. A stimulus response curve will be acquired at 30 minutes and 60 minutes post iTBS.
- One hour following TBS, a second train of TBS rTMS will be applied to the FDI 'hotspot'. TBS consists of 2s trains every 10s. Trains are composed of 3 pulses at 50Hz, 200ms intervals, 80% RMT. Total time 190s and 600 pulses.
- After TBS, twenty MEPs will be acquired (single pulse, 120% RMT, 0.25Hz) every 5 minutes for the first 15 minutes after iTBS. A stimulus response curve will be acquired at 30 minutes and 60 minutes post iTBS.
- During one of the breaks in the stimulation procedure, a brief, computerized neurocognitive assessment will take place after ingestion of the blinded capsule.
- Participants will be asked if they believe they received the study medication or placebo in this first phase of the crossover trial.
This is study involves a crossover design, therefore after a minimum of 7 days the experiment will be repeated with the second blinded capsule.
- Conditions
- Motor Activity
- Being tested
- Transcranial Magnetic Stimulation, Cycloserine, Placebo Oral Tablet
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Single-pulse transcranial magnetic stimulation and theta-burst stimulation
CycloserineDrug
Cycloserine 100mg
Placebo Oral TabletDrug
Placebo capsule matched to cycloserine capsule
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine | Experimental | Participants will ingest a capsule containing 100mg of the antibiotic d-cycloserine one hour prior to receiving theta-burst stimulation (TBS; a patterned stimulation). Their baseline motor evoked potentials (MEP) will be recorded for 20 minutes prior to receiving the first TBS to the motor cortex and change in MEP amplitude will be measured following stimulation up to 60minutes later. They will then receive a second TBS to the motor cortex and change in MEP amplitude will again be measured following stimulation up to 60minutes later. Receives: Device: Transcranial Magnetic Stimulation; Drug: Cycloserine |
| Placebo | Placebo comparator | Participants will ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule one hour prior to receiving theta-burst stimulation (TBS; a patterned stimulation). Their baseline motor evoked potentials (MEP) will be recorded for 20 minutes prior to receiving the first TBS to the motor cortex and change in MEP amplitude will be measured following stimulation up to 60minutes later. They will then receive a second TBS to the motor cortex and change in MEP amplitude will again be measured following stimulation up to 60minutes later. Receives: Device: Transcranial Magnetic Stimulation; Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulus Response Curve (SRC): Change in stability through repeated intermittent Theta Burst Stimulation (iTBS)
SRC will be characterized by collecting Motor evoked potentials (MEPs) at stimulus intensities ranging from 100-150% resting motor threshold, presented in random order. How the SRC will change following multiple rounds of iTBS will be assessed.
Measured: SRC will be administered at baseline, 30 minutes after first iTBS, 60 minutes after first iTBS, 30 minutes after second iTBS, and 60 minutes after second iTBS
Secondary outcomes (7)
Motor Evoked Potential (MEP): Amplitude Time Course
Change in the (electrical) amplitude of muscle responses to stimulation of the motor cortex will be recorded from the first dorsal interosseous muscle of the hand.
Measured: Collected at baseline, 15 minutes following first iTBS, and 15 minutes following second iTBS
Change in Cognitive Function - THINC-it- PDQ-5
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes a summation of four objective cognitive tests and a subjective cognitive questionnaire.
The cognitive questionnaire is called the Perceived Deficits Questionnaire - 5 item scale (PDQ-5). The questionnaire assesses self perceived cognition by asking questions about attention/concentration, retrospective memory, prospective memory, and planning/organization.
Total results from the THINC-it assessment indicate cognitive performance compared to healthy age-, sex- and education-matched individuals. Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Choice Reaction Time
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes a summation of four objective cognitive tests and a subjective cognitive questionnaire.
The first objective cognitive test is called "spotter" and measures choice reaction time by calculating the total time that elapses between the presentation of a stimulus and the occurrence of a response in a task that requires a participant to make one of two different responses depending on which stimuli is presented.
Total results from the THINC-it assessment indicate cognitive performance compared to healthy age-, sex- and education-matched individuals. Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Working Memory
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes a summation of four objective cognitive tests and a subjective cognitive questionnaire.
The second objective cognitive test is called "Symbol Check" and is an n-back test. N-back tests measure working memory by presenting the subject with a sequence of stimuli, and the task consists of selecting the stimuli that was presented n steps earlier in the sequence.
Total results from the THINC-it assessment indicate cognitive performance compared to healthy age-, sex- and education-matched individuals. Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Digit Symbol Substitution
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes a summation of four objective cognitive tests and a subjective cognitive questionnaire.
The third objective cognitive test is called "CodeBreaker" and is a Digit Symbol Substitution Test (DSST). DSST involves a key consisting of the numbers 1-6, each paired with a unique symbol. Below the key are a series of the numbers 1-6 in random order and repeated several times. Subjects must select the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Total results from the THINC-it assessment indicate cognitive performance compared to healthy age-, sex- and education-matched individuals. Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Trail Making Test part B
Cognitive function will be assessed using the THINC-it brief cognitive assessment tool. THINC-it includes a summation of four objective cognitive tests and a subjective cognitive questionnaire.
The fourth objective cognitive test is called "Trails" and is a version of the Trail Making Test part B (TMT-B). The subject is presented with numbers and letters in circles placed in random array on the screen. The subject must draw a line from one circle to the next in ascending order; however, s/he must alternate the circles with numbers in them and circles with letters in them (ie, 1-A-2-B-3-C etc). The TMT is a timed test and the goal is to complete the tests accurately and as quickly as possible.
Total results from the THINC-it assessment indicate cognitive performance compared to healthy age-, sex- and education-matched individuals. Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Implicit Suicidal Thoughts
Death Implicit Association Test (D-IAT) is a behavioral test that measures the strength of automatic (implicit) associations between concepts in people's minds relying on latency measures in a simple sorting task. The strength of an association between concepts of "death" and "ones self" is measured by the standardized mean difference score of the 'hypothesis-inconsistent' pairings and 'hypothesis-consistent' pairings.
Change between the two arms will be assessed.
Measured: Administered once during each crossover arm, at 30-minutes following first iTBS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start18 Aug 2021
- Primary completion6 Oct 2021
- Study completion23 Feb 2022
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 Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander McGirr, University of Calgary
- Investigators
- Alexander McGirr, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081986
- Sponsor's protocol ID
- REB21-0863
- Status last verified
- Sep 2023
- First submitted
- 27 Sep 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wrightson JG, Cole J, Sohn MN, McGirr A. The effects of D-Cycloserine on corticospinal excitability after repeated spaced intermittent theta-burst transcranial magnetic stimulation: A randomized controlled trial in healthy individuals. Neuropsychopharmacology. 2023 Jul;48(8):1217-1224. doi: 10.1038/s41386-023-01575-7. Epub 2023 Apr 11.
PubMed 37041205
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Plasticity Enhancement of Spaced iTBS Trains: a Randomized, Placebo-controlled, Crossover Trial of D-cycloserine.
- ClinicalTrials.gov ID
- NCT05081986
- Acronym / sponsor ID
- REB21-0863
- Conditions
- Motor Activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 18 Oct 2021 (actual)
- 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.
Repetitive transcranial magnetic stimulation (rTMS) is a modality for probing and altering brain function in humans non-invasively. The technology relies on the principles of electromagnetic induction, whereby magnetic fields have an associated electrical field. By intersecting two magnetic fields safely generated outside the head, one can induce a focal electrical current where the magnetic fields intersect in the brain, and this can depolarize cell membranes and impact brain activity.
A well investigated phenomenon in neuroscience is the principle of long term potentiation (LTP), and its converse long term depression (LTD), referring to the ability of neurons to increase or decrease their connection strength in an activity dependent manner. They do this through modifications to their electrochemical junctions, the synapses. We have previously used the motor system as a model system to study the impact D-Cycloserine, an NMDA receptor partial agonist, on synaptic plasticity after TMS.
Conventional therapeutic TMS is delivered once daily, however it is increasingly being delivered multiple times per day in an effort to speed treatment effects. It is unclear how adjunctive agents would impact these repeated stimulation designs.
Research Question:
Does the N-methyl-D-aspartate receptor partial agonist D-Cycloserine stabilize motor plasticity across multiple daily sessions of TMS?
Detailed description
Objectives:
- To recruit 20 participants into a cross-over trial. These participants will complete two study phases (active and placebo), and will not know whether they are taking a low-dose d-cycloserine capsule (100mg) or a placebo capsule at each of these phases.
- To measure motor evoked potentials (MEP) in the hand in relation to magnetic stimulation of the motor cortex responsible for this muscle. These will be measured at baseline, and after receiving rTMS over the motor cortex.
- To deliver intermittent theta-burst rTMS stimulation (TBS) to the FDI region of the motor cortex.
- To measure the magnitude (and associated change from baseline) of the MEPs after rTMS at a fixed stimulus intensity, and using a range of stimuli to generate a stimulus response curve.
- To repeat iTBS one hour later and measure the impact on MEPs.
- To measure changes in performance on computerized cognitive tasks following ingestion of the blinded capsule.
Methods:
D-Cycloserine will be purchased from Parsolex and repackaged into 100mg placebo-controlled capsules by Script Pharmacy in Calgary.
- We will recruit 20 participants aged 18-65 through community advertisement, carefully screened for exclusion factors related to rTMS and DCS.
- Participants will be randomly assigned by random number sequence with allocation concealment to one of two first arms of the crossover study: a) placebo-DCS 100mg and b) DCS 100mg-placebo.
- Participants will complete the QIDS-SR (Quick Inventory of Depressive Symptoms-Self Report), the BAI (Beck Anxiety Inventory), and the STAI (State Trait Anxiety Inventory).
- Participants will take their blinded capsule at least 1 hour prior to TBS. (we anticipate that it will take approximately 30 minutes to do steps 5-7)
- Electromyographic (EMG) electrodes will be positioned over the first dorsal interosseous (FDI) bilaterally. These are non-invasive electrodes that use an adhesive to stick to the skin.
- Using neuronavigation in conjunction with an atlas brain, the M1 hand strip will be localized using single pulse TMS (MagPro X100).
- Motor evoked potentials are measurements of muscle activation, in this case in response to TMS stimulation of the brain. We will use single pulse TMS to record the magnitude of responses. As a baseline, we will collect twenty single-pulse (120% resting motor threshold (RMT), 0.25Hz) MEPs every 5 minutes for the 15 minutes preceding TBS rTMS. We will also characterize the stimulus response curve at baseline by delivering single pulse TMS at stimulus intensities ranging from 100-150% resting motor threshold presented in random order.
- TBS rTMS will be applied to the FDI 'hotspot'. TBS consists of 2s trains every 10s. Trains are composed of 3 pulses at 50Hz, 200ms intervals, 80% RMT. Total time 190s and 600 pulses.
- After TBS, twenty MEPs will be acquired (single pulse, 120% RMT, 0.25Hz) every 5 minutes for the first 15 minutes after iTBS. A stimulus response curve will be acquired at 30 minutes and 60 minutes post iTBS.
- One hour following TBS, a second train of TBS rTMS will be applied to the FDI 'hotspot'. TBS consists of 2s trains every 10s. Trains are composed of 3 pulses at 50Hz, 200ms intervals, 80% RMT. Total time 190s and 600 pulses.
- After TBS, twenty MEPs will be acquired (single pulse, 120% RMT, 0.25Hz) every 5 minutes for the first 15 minutes after iTBS. A stimulus response curve will be acquired at 30 minutes and 60 minutes post iTBS.
- During one of the breaks in the stimulation procedure, a brief, computerized neurocognitive assessment will take place after ingestion of the blinded capsule.
- Participants will be asked if they believe they received the study medication or placebo in this first phase of the crossover trial.
This is study involves a crossover design, therefore after a minimum of 7 days the experiment will be repeated with the second blinded capsule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine | Experimental | Device: Transcranial Magnetic Stimulation, Drug: CycloserineParticipants will ingest a capsule containing 100mg of the antibiotic d-cycloserine one hour prior to receiving theta-burst stimulation (TBS; a patterned stimulation). Their baseline motor evoked potentials (MEP) will be recorded for 20 minutes prior to receiving the first TBS to the motor cortex and change in MEP amplitude will be measured following stimulation up to 60minutes later. They will then receive a second TBS to the motor cortex and change in MEP amplitude will again be measured following stimulation up to 60minutes later. |
| Placebo | Placebo comparator | Device: Transcranial Magnetic Stimulation, Drug: Placebo Oral TabletParticipants will ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. They will ingest this capsule one hour prior to receiving theta-burst stimulation (TBS; a patterned stimulation). Their baseline motor evoked potentials (MEP) will be recorded for 20 minutes prior to receiving the first TBS to the motor cortex and change in MEP amplitude will be measured following stimulation up to 60minutes later. They will then receive a second TBS to the motor cortex and change in MEP amplitude will again be measured following stimulation up to 60minutes later. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy (absence of chronic medical conditions) individuals
- Aged 18-65. The lower limit is justified by the absence of safety studies involving DCS in pediatric studies, and the upper limit is justified by the increasing prevalence of chronic illness.
Key exclusion criteria (12 listed)
- Allergy to cycloserine
- Are currently pregnant, breast feeding or plan to become pregnant
- Have an alcohol or substance use disorder within the last 3 months
- Current psychiatric concerns
- are at a significant risk of harm to themselves or others
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 |
|---|---|---|
| Transcranial Magnetic StimulationSingle-pulse transcranial magnetic stimulation and theta-burst stimulation | Device | D-cycloserine, Placebo |
| CycloserineCycloserine 100mg | Drug | D-cycloserine |
| Placebo Oral TabletPlacebo capsule matched to cycloserine capsule | Drug | Placebo |
Primary outcome
Stimulus Response Curve (SRC): Change in stability through repeated intermittent Theta Burst Stimulation (iTBS)
Time frame: SRC will be administered at baseline, 30 minutes after first iTBS, 60 minutes after first iTBS, 30 minutes after second iTBS, and 60 minutes after second iTBS
SRC will be characterized by collecting Motor evoked potentials (MEPs) at stimulus intensities ranging from 100-150% resting motor threshold, presented in random order. How the SRC will change following multiple rounds of iTBS will be assessed.
7 secondary outcomes
Motor Evoked Potential (MEP): Amplitude Time Course
Time frame: Collected at baseline, 15 minutes following first iTBS, and 15 minutes following second iTBS
Change in Cognitive Function - THINC-it- PDQ-5
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Choice Reaction Time
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Working Memory
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Digit Symbol Substitution
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Cognitive Function - THINC-it- Trail Making Test part B
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
Change in Implicit Suicidal Thoughts
Time frame: Administered once during each crossover arm, at 30-minutes following first iTBS.
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 7 Sep 2023.
- Derived from this study: PubMed 37041205Wrightson JG, Cole J, Sohn MN, McGirr A. The effects of D-Cycloserine on corticospinal excitability after repeated spaced intermittent theta-burst transcranial magnetic stimulation: A randomized controlled trial in healthy individuals. Neuropsychopharmacology. 2023 Jul;48(8):1217-1224. doi: 10.1038/s41386-023-01575-7. Epub 2023 Apr 11.
- Individual participant dataSharing planned: No
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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.
Alexander McGirr, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation and Cycloserine in people with Motor Activity, run by University of Calgary 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 2 inclusion and 12 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 7 Sep 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Stimulus Response Curve (SRC): Change in stability through repeated intermittent Theta Burst Stimulation (iTBS) (time frame: SRC will be administered at baseline, 30 minutes after first iTBS, 60 minutes after first iTBS, 30 minutes after second iTBS, and 60 minutes after second iTBS). 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 NCT05081986, 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 7 Sep 2023; AzTrials last refreshed its copy on 2 Nov 2026.