NCT07123272

Brief Summary

The Me Time MS Application was designed to enable self-administration of acupressure. Two forms of acupressure - either "relaxing" or "stimulating" protocols - are administered through the Me Time MS app. The goal of this study is to assess the usability of the Me Time MS app in a sample of 10 adults with multiple sclerosis (MS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 14, 2025

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 20, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

August 7, 2025

Results QC Date

September 26, 2025

Last Update Submit

November 7, 2025

Conditions

Keywords

chronic painacupressuredigital healthfatigueusabilityfeasibility

Outcome Measures

Primary Outcomes (1)

  • Participant Perception of Me Time MS App Usability

    Qualitative descriptions of positive, negative, and neutral aspects of usability of the Me Time MS app, gathered through one-on-one, open-ended interviews after 6 weeks of access to the app. Results reflect the total number of comments across all participants that were provided for each category. Participants could submit multiple types of comments.

    Up to 2 weeks after the 6-week app usage period ended

Secondary Outcomes (1)

  • System Usability Scale (SUS) Adapted for the MeTime MS App

    Up to 2 weeks after the 6-week app usage period ended

Study Arms (2)

Relaxing Self-Acupressure

EXPERIMENTAL

Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks.

Behavioral: Self-guided smartphone application for relaxing acupressure

Stimulating Self-Acupressure

EXPERIMENTAL

Self-guided use of a smartphone app that informs users how to administer relaxing acupressure each day for 6 weeks.

Behavioral: Self-guided smartphone application for stimulating acupressure

Interventions

Relaxing Acupressure entails applying pressure with either a finger, pencil, or similar object to acupressure points. For the relaxing protocol, there is a total of 9 acupoints (1 unilateral and 4 bilateral). Each point will be stimulated for 3 minutes, yielding a total treatment time of 27 minutes each day. The acupoints are: 1. Yin Tang (Unilaterally): Located on the forehead, between the eyebrows. 2. Anmian (Right and Left/bilaterally): Located on the posterior aspect of the neck, in a slight depression along the bone directly behind the ear. 3. Heart 7 (HT7) (Right and Left/bilaterally): Located on the palmer surface of the hands on the wrist crease; in line with the pinky. 4. Spleen 6 (SP6) (Right and Left/bilaterally): Located on the inside of the lower leg, approximately 4 fingers width above the bone of the ankle. 5. Liver 3 (LIV3) (Right and Left/bilaterally): This point is located on the foot, near the big and second toes.

Also known as: Me Time MS
Relaxing Self-Acupressure

There is a total of 10 acupoints (2 unilateral and 4 bilateral). Each point is stimulated for 3 minutes, yielding a total treatment time of 30 minutes each day. The acupoints are: 1. Du 20 (Unilaterally): Located at the top of the head. 2. Large Intestine 4 (LI4) (Right and Left/bilaterally): Located on the back of the hand, between your thumb and index finger. 3. Conception Vessel 6 (CV6) (Unilaterally): Located two finger widths below the navel on the centerline. 4. Stomach 36 (ST36) (Right and Left/bilaterally): Located on the lower leg below the knee on the outside of the leg. 5. Spleen 6 (SP6) (Right and Left/bilaterally): Located on the inside of the lower leg, approximately 4 fingers width above the bone of the ankle. 6. Kidney 3 (K3) (Right and Left/bilaterally): Located on the inside of the ankle.

Also known as: Me Time MS
Stimulating Self-Acupressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • MS diagnosis (all MS subtypes included)
  • Age 18 years or older
  • Average Fatigue Severity Scale (FSS) score ≥ 4 at screening coupled with the opinion of the volunteer that the fatigue has interfered with their daily activities for ≥ 3 months
  • Presence of chronic pain defined as moderate to severe pain for ≥ 3-month duration that is ≥ 4 on average using a 0-10 numerical rating scale
  • Home access to internet via Wi-Fi or cellular data
  • Active email account

You may not qualify if:

  • Not fluent in English
  • Pregnancy or breast feeding, or anticipate pregnancy in next 6 months
  • Inability to use smartphone/tablet and/or MeTime MS mobile app
  • Anything at the discretion of the PI or study team that would preclude participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Multiple SclerosisPainFatigueChronic Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Anna Kratz
Organization
University of Michigan

Study Officials

  • Anna Kratz, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investogator

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 14, 2025

Study Start

March 17, 2025

Primary Completion

May 16, 2025

Study Completion

May 16, 2025

Last Updated

November 20, 2025

Results First Posted

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

This study's limited qualitative data focused on digital health tool usability is not relevant outside of our efforts to optimize the digital health tool (Me Time MS); therefore release of qualitative data is not planned.

Locations