Transcranial Pulse Stimulation on Motor Cortex

Healthy Adults Clinical Trial

Official title:

Neuromodulation of Transcranial Pulse Stimulation on Primary Motor Cortex in Adults: A Randomized, Cross-over, Single-blind, Sham-controlled, Pilot Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312930
• Other study ID #: HSEARS20220816001-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: August 20, 2024

Study information

• Verified date: March 2024
• Source: The Hong Kong Polytechnic University
• Contact: Georg Kranz, PhD
• Phone: 27664838
• Email: georg.kranz[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Transcranial pulse stimulation (TPS) is a newly developed non-invasive brain stimulation (NIBS) technique from Austria & Germany with highly promising applicability in neuropsychiatric disorders. Clinical trials have shown a beneficial effect of TPS in patients with Alzheimer's disease and depression. However, the mechanism of action of TPS treatment is unknown. There is a lack of controlled studies with sufficient sample size to draw reliable conclusions on the modulatory effect of TPS. The primary motor cortex is a common target when investigating the neuromodulation effect of NIBS techniques. Here, a randomized, cross-over, double-blind, sham-controlled clinical trial is proposed to probe the effects of TPS over the primary motor cortex on modulating motor response and motor behavior.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 to 65

• No physical, neurological or psychiatric disorder

• Right-handedness

Exclusion Criteria:

• Background with neuroscience

• TPS and TMS contraindications, including metal implants, pregnancy, coagulation disorders, thrombosis, brain tumor, cortisone therapy up to 6 weeks before first stimulation, pacemakers or cochlear implants.

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Device:
• Transcranial pulse stimulation
A single session of TPS will be performed, applying 1000 pulses in the session (single ultrashort (3 µs) ultrasound pulses, 0.2-0.25 mJ mm-2, ~5 Hz pulse frequency)

Locations

Country	Name	City	State
Hong Kong	Georg Kranz, PhD	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in movement time in nine-hole peg test after TPS	Primary clinical outcome measure will be a change in movement time in nine-hole peg test after TPS. Less movement time is indicative of greater improvement in hand dexterity and motor function.	Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Primary	Change in reaction time in Deary-Liewald reaction time task after TPS	Primary clinical outcome measure will be a change in reaction time in Deary-Liewald reaction time task after TPS. Less reaction time is indicative of greater improvement in motor function.	Immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS
Secondary	The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS task performance measured by nine-hole peg test and Deary-Liewald reaction time task	The RMT will be measured before the TPS, which is indicative of the motor excitability. The investigators will explore whether the variability of motor excitability will influence the post-TPS visuomotor performance measured by the nine-hole peg test and the Deary-Liewald reaction time task	30 minutes before TPS session, immediately after the completion of the single session TPS, 10 minutes after the single session TPS, 20 minutes after the single session TPS, 30 minutes after the single session TPS, 40 minutes after the single session TPS