The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy
CompletedNAResults postedLast updated 3 May 2024
What this trial tests
NA trial testing intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle in Healthy in 12 participants. Completed in 8 July 2022.
Timeline
9 November 2020
Primary endpoint 8 July 2022
8 July 2022
Quick facts
Lead sponsor
Virginia Commonwealth University
Phase
NA
Status
Completed
Study type
INTERVENTIONAL
Allocation
randomized
Design
crossover
Masking
none
Primary purpose
basic science
Enrollment
12
Start date
9 November 2020
Primary completion
8 July 2022
Estimated completion
8 July 2022
Sites
1 location across United States
Drugs / interventions tested
intermittent theta burst stimulation (iTBS) with sham and then active stimulation over bicep muscle
intermittent theta burst stimulation (iTBS) with sham and then active stimulation over finger muscle
Adults 18 to 65, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Corticomotor Excitability With Active Stimulation on Bicep MusclePrimary· approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Group
Value
95% CI
All Study Participants
6.9
± 3.4
Change in Corticomotor Excitability With Sham Stimulation on Bicep MusclePrimary· approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Group
Value
95% CI
All Study Participants
4.4
± 3.2
Change in Corticomotor Excitability With Active Stimulation on Finger MusclePrimary· approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Group
Value
95% CI
All Study Participants
8.6
± 5.4
Change in Corticomotor Excitability With Sham Stimulation on Finger MusclePrimary· approximately 7 days
The amplitude the motor evoked potentials (MEPS) will be used to determine level of corticomotor excitability
Group
Value
95% CI
All Study Participants
4.2
± 3.1
Sponsor's own description
The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Virginia Commonwealth University
Last refreshed: 3 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04586387.