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Transcranial Pulse Stimulation on Motor Cortex

Not Applicable
Recruiting
Conditions
Healthy Adults
Interventions
Device: Transcranial pulse stimulation
Registration Number
NCT06312930
Lead Sponsor
The Hong Kong Polytechnic University
Brief 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, single-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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Real TPS groupTranscranial pulse stimulation1. Healthy adults aged 18-65 years old will receive one single session of real TPS on the primary motor cortex. 2. Before and after TPS, participants will perform two visuomotor tasks (a simple reaction time task and a nine-hole peg test). 3. The stimulation target on the primary motor cortex will be determined by transcranial magnetic stimulation (TMS). Measurements of the resting motor threshold by TMS will be conducted for each participant before the real TPS session.
Sham TPS groupTranscranial pulse stimulationSham stimulation comprises TPS on the vertex as the control region (sham control). Stimulation duration, intensity, as well as pre- and post stimulation assessments are the same as in the experimental arm. In this cross-over study, the order of the real and sham stimulation conditions will be randomized and separated by 24 hours.
Primary Outcome Measures
NameTimeMethod
Change in reaction time in Deary-Liewald reaction time task after TPSImmediately 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 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.

Change in movement time in nine-hole peg test after TPSImmediately 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 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.

Secondary Outcome Measures
NameTimeMethod
The influence of motor excitability measured by resting motor threshold (RMT) on post-TPS motor performance30 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

The RMT will be measured before the TPS, which is indicative of the motor excitability. The investigators will explore the correlation between the RMT and post-TPS motor performance measured by the nine-hole peg test; as well as explore correlation between RMT and post-TPS motor performance measured by the Deary-Liewald reaction time task.

Trial Locations

Locations (1)

Georg Kranz, PhD

🇭🇰

Hong Kong, Hung Hom, Kowloon, Hong Kong

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