Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID06178952

Transcranial Pulse Stimulation (TPS) to Treat Neurological Symptoms in Post-COVID-19 Syndrome

Led by Medical University of Vienna · Updated on 2025-12-23

102

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of transcranial pulse stimulation (TPS) for treating neurological symptoms related to Post-COVID-19, including fatigue, cognitive problems, and mood changes. This study uses a double-blind, randomized, placebo-controlled design to compare the active TPS treatment with a sham (placebo) procedure. The primary goal is to measure fatigue improvement using the Fatigue Impact Scale (FIS). Participants will be randomly assigned to receive either five sessions of active TPS or five sessions of sham TPS over 10 days, with one daily session lasting about 30 minutes. The TPS treatment uses the NEUROLITH device, which delivers non-invasive ultrasound pulses to the brain. The sham treatment mimics the active procedure without delivering pulses. Assessments occur at baseline, shortly after treatment, and one month later, with additional follow-ups planned up to two years to monitor long-term effects. During the study, participants will undergo multiple assessments including fatigue, depression, cognitive function, quality of life, anxiety, and brain imaging at each main time point. The study also collects limited data at later intervals up to 24 months post-treatment. The total active participation period is about 3 to 4 months, with careful monitoring and evaluation of symptoms and treatment effects throughout the trial to understand the impact of TPS on Post-COVID-19 neurological symptoms.

CONDITIONS

Brief Title

Transcranial Pulse Stimulation (TPS) in Post-COVID-19

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent
  • Confirmed COVID-19 infection (PCR, antibody test, or physician-verified)
  • At least 12 months since initial COVID-19 infection
  • Diagnosis or suspected diagnosis of Post-COVID Syndrome
  • Age between 20 and 80 years
  • Negative pregnancy test if medically applicable
Not Eligible

You will not qualify if you...

  • Significant pre-COVID diseases with symptoms similar to Post-COVID
  • Montreal Cognitive Assessment score below 17
  • Beck Depression Inventory score 29 or higher
  • Fatigue Impact Scale score below 10
  • Brain implants or metal parts in the head
  • Use of anticoagulant medications
  • Claustrophobia or pacemaker incompatible with MRI
  • Pregnant or breastfeeding women
  • History of surgery on head, heart, or blood vessels
  • Recent corticosteroid treatment within 6 weeks
  • Head tumors relevant for treatment
  • Blood clotting disorders
  • Participation in other clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 2 weeks

Participants are screened for eligibility to participate in the trial.

3 to 4 assessment sessions within 14 days including informed consent

Implementation

Duration - 10 days

Participants receive five transcranial pulse stimulation sessions over 10 days, with one session per day lasting approximately 30 minutes. Treatment may be verum or sham in a randomized, double-blind design.

5 in-person stimulation sessions

Post-stimulation Assessment

Duration - Up to 1 week

Participants undergo assessments during the week following brain stimulation to evaluate treatment effects.

2 to 3 assessment sessions within 7 days

One-month Post-stimulation Assessment

Duration - Up to 1 week

Participants return for follow-up assessments one month after the brain stimulation to monitor ongoing effects.

2 to 3 assessment sessions within 7 days

Long-term Monitoring

Duration - Up to 24 months

Limited data collection occurs at 3, 6, 12, and 24 months post-stimulation to assess long-term outcomes related to fatigue, depression, quality of life, and post-exertional malaise.

Assessments at 3, 6, 12, and 24 months post-stimulation

Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, State of Vienna, Austria, 1090

Actively Recruiting

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Research Team

R

Roland Beisteiner, Prof.

M

Michael Mitterwallner, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A systematic review of trials currently investigating therapeutic modalities for post-acute COVID-19 syndrome and registered on WHO International Clinical Trials Platform.

Nader Ashraf, Bader Abou Shaar, Rand M Taha...

https://pubmed.ncbi.nlm.nih.gov/36642173

The therapeutic potential of non-invasive brain stimulation for the treatment of Long-COVID-related cognitive fatigue.

Stefanie Linnhoff, Lilli Koehler, Aiden Haghikia...

https://pubmed.ncbi.nlm.nih.gov/36700201