Transcranial Pulse Stimulation on Motor Cortex

The Hong Kong Polytechnic University

Status: Completed

Conditions: Healthy Adults

Treatments: Device: Transcranial pulse stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06312930

HSEARS20220816001-03

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Real TPS group

Experimental group

Description:

1. 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.

Treatment:

Device: Transcranial pulse stimulation

Sham TPS group

Sham Comparator group

Description:

Sham 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.

Treatment:

Device: Transcranial pulse stimulation