ClinicalTrials.gg
CompletedNCT03432689Updated Nov 9, 2018

Cycloserine rTMS Plasticity Augmentation

A Phase 1 interventional study of Transcranial Magnetic Stimulation and Cycloserine in Motor Activity, sponsored by University of Calgary. Completed at 1 site in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-09.

Sponsored by University of Calgary · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Nov 2018, 8 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Motor Activity by University of Calgary — 12 open to participants now, 14 under way, none of them phase 3. Motor Activity · University of Calgary.

Enrollment
30th of 32
12 · median 39
Started
2018
the only one that year
Phase 1
4 of 32
1 open now
Registered
10th of 32
by date

Among the 32 studies in Motor Activity by University of Calgary, this one is the 30th largest by enrollment, is the only one that started in 2018, is one of 4 in phase 1, and was the 10th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

12 of the 32 studies in Motor Activity by University of Calgary are open now, in 1 country. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 12 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study summary

Transcranial magnetic stimulation (rTMS) is an investigational and therapeutic modality that impacts the connection strength between neurons by delivering patterned energy. In response to this patterned energy neurons fire and adapt by changing their connection strengths. This change in connection strengths is believed to be the underlying mechanism whereby this intervention has therapeutic benefit for this intervention in conditions such as depression. The purpose of this study is to test a means of enhancing the effect of rTMS using a medication (cycloserine) that has been shown to augment and stabilize activity dependent neuronal changes. The investigators wish to use the motor system, where the associated muscle response to brain stimulation can be measured, to probe activity dependent changes in connection strength between neurons.

Read the detailed description

This randomized, placebo-controlled, crossover trial will enroll 12 healthy participants. In one arm of the study, participants will randomly receive either 100mg of d-cycloserine (DCS, an antibiotic) or a placebo capsule, and participants will receive the other intervention one week later.

  1. The investigators will recruit 12 healthy participants through community advertisement, carefully screened for exclusion factors related to rTMS and DCS.
  2. 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.
  3. Participants will complete the QIDS-SR (Quick Inventory of Depressive Symptoms-Self Report), the MDQ (Mood Disorders Questionnaire), the BAI (Beck Anxiety Inventory), and the STAI (State Trait Anxiety Inventory).
  4. Participants will take their blinded capsule at least 30 minutes hours prior to TBS. (we anticipate that it will take approximately 30 minutes to do steps 5-7).
  5. Electromyographic (EMG) electrodes will be positioned over the first dorsal interosseous (FDI) bilaterally to record motor evoked potentials (MEPs). These are non-invasive electrodes that use an adhesive to stick to the skin.
  6. Using neuronavigation in conjunction with an atlas brain, the M1 hand strip will be localized using single pulse TMS (MagPro X100).
  7. Motor evoked potentials are measurements of muscle activation, in this case in response to TMS stimulation of the brain. The investigators will use single pulse TMS to record the magnitude of responses. As a baseline, the investigators will collect twenty single-pulse (120% resting motor threshold (RMT), 0.25Hz) MEPs every 5 minutes for the 15 minutes preceding TBS rTMS.
  8. 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.
  9. After TBS, twenty MEPs will be acquired (single pulse, 120% RMT, 0.25Hz) every 5 minutes for the first 30 minutes, at 60 minutes, at 90 minutes, and at 16Hrs (the following morning).
  10. At the 16 Hrs time point, the investigators will characterize stimulus response curves (MEPs at stimulus intensities ranging from 100-150% resting motor threshold presented in random order).

As this is a cross-over study, participants will return 1 week later to repeat the second arm of the protocol and will repeat steps 2-10).

03

Conditions studied

  • Motor Activity

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy individuals 18-60 years of age.

Exclusion criteria

Exclusion Criteria:

  1. Pregnancy
  2. Lactation
  3. Epilepsy
  4. Previous Stroke
  5. Current Renal Disease
  6. Current Liver Disease
  7. Current Alcohol Use Disorder
  8. Inability to refrain from alcohol use for 24 hours prior to each session and following each session.
  9. Allergy to antibiotics
  10. Use of isoniazid, ethionamide or bupropion
  11. Current psychiatric concerns
  12. History of bipolar disorder
  13. Family history of bipolar disorder
  14. Intracranial implants (dental implants are not an exclusion criteria)
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    D-Cycloserine

    Participants will ingest a capsule containing 100mg of the antibiotic d-cycloserine. Their baseline motor evoked potentials (MEP) will be recorded for 30 minutes prior to receiving theta-burst stimulation (TBS; a patterned stimulation) to the motor cortex and change in MEP amplitude will be measured following stimulation up to 90 minutes later and then once again the following morning (16 hours later).

    Device: Transcranial Magnetic Stimulation · Drug: Cycloserine

  • Placebo comparator
    Placebo

    Participants will ingest a capsule identical to that containing the study medication, however this capsule will contain a placebo. Their baseline motor evoked potentials (MEP) will be recorded for 30 minutes prior to receiving theta-burst stimulation (TBS; a patterned stimulation) to the motor cortex and change in MEP amplitude will be measured following stimulation up to 90 minutes later and then once again the following morning (16 hours later).

    Device: Transcranial Magnetic Stimulation · Drug: Placebo Oral Tablet

Interventions

  • DeviceTranscranial Magnetic Stimulation

    Single-pulse transcranial magnetic stimulation and theta-burst stimulation

  • Cycloserine 100mg

  • DrugPlacebo Oral Tablet

    Placebo capsule matched to cycloserine capsule

06

What researchers measure

Primary outcomes

  1. Motor Evoked Potential amplitude

    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.

    Time frame: Baseline versus 90 minutes following theta-burst stimulation.

Secondary outcomes

  1. Motor Evoked Potential dose-response curve

    Motor Evoked Potentials at stimulus intensities ranging from 100-150% resting motor threshold, presented in random order.

    Time frame: Baseline versus 90 minutes following theta-burst stimulation.

  2. Motor Evoked Potential dose-response curve

    Motor Evoked Potentials at stimulus intensities ranging from 100-150% resting motor threshold, presented in random order.

    Time frame: Baseline versus 16 hours following theta-burst stimulation.

  3. Motor Evoked Potential 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.

    Time frame: 90 minutes following theta-burst stimulation.

Other outcomes

  1. Safety outcomes

    Adverse events will be tracked and recorded

    Time frame: Through study completion, on average 2 weeks.

  2. Side effects

    Side effects will be tracked with the Toronto Side Effects Questionnaire

    Time frame: Pre-stimulus and 16 hours post-stimulus for both arms of the crossover study.

07

Study locations

1 site
  • University of Calgary
    Calgary, Alberta T2N1N4, Canada
08

References and documents

Individual participant data

Plan to share: Yes — There will be no sharing of individual participant data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2018 to primary completion in Nov 2018, 3 months.

Of 73 non-industry phase 1 interventional studies under Motor Activity, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 3 months is below that.

Counting every sponsor, half of 75 studies reached it within 20 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2018
First posted
Feb 14, 2018
StartActual
Aug 6, 2018
Primary completionActual
Nov 7, 2018
CompletionActual
Nov 7, 2018
Last update
Nov 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03432689
Responsible party
Alexander McGirr (Assistant Professor, University of Calgary) — Principal investigator
First posted
Feb 14, 2018
Start date
Aug 6, 2018
Primary completion
Nov 7, 2018
Completion
Nov 7, 2018
Last update
Nov 9, 2018

Study contacts

Alexander McGirr, MD MSc
principal investigator · University of Calgary

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cycloserine

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