COMPLETED

Effects of Transcranial Pulse Stimulation in Parkinson's Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are studying if Transcranial Pulse Stimulation (TPS) can improve various symptoms, including movement problems, thinking abilities, mood, fatigue, freezing while walking, voice quality, and issues with smell and taste. Previous research suggests TPS might help in Alzheimer's disease and could be helpful for Parkinson's as well. Investigators will check if TPS is safe, practical, and if it makes a noticeable difference in these symptoms compared to before the treatment.

Official Title

Parkinson's Disease: Overall Symptoms Improvement With Transcranial Pulse Stimulation (TPS)

Quick Facts

Study Start:2024-12-31

Study Completion:2025-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06676995

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician. 2. Age from 40 to 90 years old. 3. Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale). 4. Taking stable medications for PD for at least 30 days.	1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes. 2. History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions. 3. History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months. 4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality. 5. Contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, CNS thrombosis, etc). 6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease). 7. Contraindications to MRI according to MGB screening in the Martinos-Center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with MRI). 8. Pregnancy. 9. Epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes. 10. Bed- or wheelchair-bound patients.

Inclusion Criteria

Exclusion Criteria

1. Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician.
2. Age from 40 to 90 years old.
3. Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
4. Taking stable medications for PD for at least 30 days.

1. Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes.
2. History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions.
3. History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
4. Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
5. Contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, CNS thrombosis, etc).
6. Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).
7. Contraindications to MRI according to MGB screening in the Martinos-Center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with MRI).
8. Pregnancy.
9. Epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes.
10. Bed- or wheelchair-bound patients.

Contacts and Locations

Study Locations (Sites)

Spaulding Rehabilitation Hospital

Cambridge, Massachusetts, 02138

United States

Collaborators and Investigators

Sponsor: Spaulding Rehabilitation Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-31

Study Completion Date2025-07-30

Study Record Updates

Study Start Date2024-12-31

Study Completion Date2025-07-30

Terms related to this study

Additional Relevant MeSH Terms

Parkinson