PEM, a Starting Point to Investigate ME/CFS
NCT07715838, Recruiting, University Medical Center Groningen
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | PEM, a Starting Point to Investigate ME/CFS | ClinicalTrials.gov |
| NCT number | NCT07715838 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University Medical Center Groningen | ClinicalTrials.gov |
| Conditions | Myalgic Encephalomyelitis / Chronic Fatigue Syndrome | ClinicalTrials.gov |
| Interventions | No intervention is planned | ClinicalTrials.gov |
| First posted | 2026-07-21 | ClinicalTrials.gov |
| Last updated | 2026-07-21 | ClinicalTrials.gov |
Registered outcomes 24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cardiovascular parameters (Heart rate and blood pressure) | 2023-2027 | Heart rate (bpm) and blood pressure (mmHg) are measured with a continuous non-invasive monitoring system (Finapres Midi). The BP sensor is positioned around the middle finger on the second phalanx of the left hand and subjects must hold their arm at breast level. The recorded values during T1 and T2 will be compared between tasks, as well as between groups and sessions. | ClinicalTrials.gov |
| Primary | Short maximal voluntary contraction | 2023-2027 | Short isometric maximal voluntary contractions (MVC) of the right index finger abductor (FDI). The maximal index finger abduction force (newton) is measured with a force transducer which is held by the participant. The measurement is repeated 3 times per hand and the highest value is taken. On the second and third repetition, a superimposed twitch stimulation (SIT) will be induced to assess the voluntary activation during maximal contraction. | ClinicalTrials.gov |
| Primary | Submaximal voluntary contractions (20%,40%, 60% of the short MVC) | 2023-2027 | The participant is asked to produce force at different submaximal force targets (20%, 40%, 60%). The targets are presented on a monitor and subjects get online feedback of the target force and their produced force. | ClinicalTrials.gov |
| Primary | Sustained maximal voluntary contraction of the FDI | 2023-2027 | The participant performs a maximal contraction for 2 minutes. During the 2 minutes contraction 7 SIT stimulation are given to the subject to assess voluntary muscle activation during a fatiguing task. | ClinicalTrials.gov |
| Primary | Cognitive parameters (stroop task) | 2023-2027 | This test assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus. Participants see a word describing a colour on a screen, the word is written in the same or different colour than the word they will read. They are asked to press a yes or no button to indicate whether the colour of the word and the meaning of the word matches (yes) or not (no). The number of correct answers and the reaction time will be assessed. | ClinicalTrials.gov |
| Primary | BOLD activation | 2023-2027 | Blood oxygenation level dependent (BOLD): changes both in oxy- and deoxyhemoglobin concentration. Brain activation in different tasks will be compared between groups and sessions. | ClinicalTrials.gov |
| Primary | Arterial Spin Labeling (ASL) | 2023-2027 | Is a non-invasive fMRI technique that uses arterial water as an endogenous tracer to measure cerebral blood flow. ASL provides reliable absolute quantification of cerebral blood flow with high spatial and temporal resolution. Perfusion data are used to identify patients suffering from impaired autoregulation of cerebral blood flow and to obtain associations with cardiovascular responses and muscle fatigue. | ClinicalTrials.gov |
| Primary | Cerebral oxygenation (near infrared spectroscopy) | 2023-2027 | Oxy- and deoxyhemoglobine concentrations are measured at the prefrontal cortex and leg muscle with a non-invasive near infrared spectroscopy device (NIRS), where small sensors are positioned on the forehead and the quadriceps muscle. For this measurement a standardized vascular occlusion test will be performed on the quadriceps muscle to assess the local tissue oxygen consumption and the microvascular reperfusion and reactivity. This measurement will be used as calibration to normalize per subject the oxy- and deoxyhemoglobin concentrations allowing for comparisons between subjects. The oxygenated and deoxygenated values for the prefrontal cortex and leg muscle will be compared across tasks, groups and sessions. | ClinicalTrials.gov |
| Secondary | 30 Chair to stand test | 2023-2027 | This test assesses functional lower extremity strength. Subjects sit on a chair and stand up repeatedly for 30 s. Arms of the subject are crossed and held against the chest. The number of cycles of standing up from sitting are counted. | ClinicalTrials.gov |
| Secondary | Handgrip force (kg) | 2023-2027 | MVC of the handgrip is measured with a hydraulic hand dynamometer (JAMAR Hand Dynamometer). The measurement is repeated 3 times. | ClinicalTrials.gov |
| Secondary | Activity monitor | 2023-2027 | To measure routine activities in daily life, participants will be asked to wear an activity device (Actigraph) on their dominant hip as well as a heart rate device (polar H10) around their chest. During the 7 days of wearing the devices participant will be asked to fill out an activity diary. The difference in activity level and heart rate variables will be compared across the groups. | ClinicalTrials.gov |
| Secondary | Blood samples | 2023-2027 | The blood samples are used to analyse the short-lasting changes in metabolites before and after the performance of physical and cognitive tasks and long-lasting changes on the next day | ClinicalTrials.gov |
| Secondary | Knee extension force | 2023-2027 | Maximal voluntary force (MVC) of the knee extensors is measured with a custom-built dynamometer. Subjects are seated in a chair with the knee and hip in 90° of flexion with their non-dominant lower leg strapped to the chair's lever arm (\~ 10 cm up to lateral malleolus). Subjects are instructed to contract their knee extensors as rapidly and forcefully as possible and to maintain force generation for 5 s. MVC is determined as the peak force. | ClinicalTrials.gov |
| Secondary | Chalder fatigue scale | 2023-2027 | Is a questionnaire used to measure the severity of tiredness in fatiguing illnesses. Scores per question range from 0 to 3. The higher the score the more fatigue experienced. | ClinicalTrials.gov |
| Secondary | SF-36 | 2023-2027 | It is a multipurpose, short-form health survey with 36 questions. It yields an eight-scale profile of scores as well as physical and mental health summary measures. It is useful in comparing general and specific populations and comparing the relative burden of diseases. Higher scores indicate a better health status. | ClinicalTrials.gov |
| Secondary | DePaul Symptoms Questionnaire 2 (DSQ-2) | 2023-2027 | DSQ-2 is a questionnaire that assesses the key symptoms of ME/CFS. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. The higher the scores the worse the symptoms. | ClinicalTrials.gov |
| Secondary | Bell disability scale | 2023-2027 | Bell scale is a scale that describes the levels of physical and mental activity health. The scores range from 0 to 100, the higher the score the better the health. | ClinicalTrials.gov |
| Secondary | Pittsburgh sleep quality index | 2023-2027 | Is a questionnaire assessing sleep quality and disturbances. The higher the score the worse the sleep quality. | ClinicalTrials.gov |
| Secondary | Hospital Anxiety and Depression Scale | 2023-2027 | Is a questionnaire to determine levels of anxiety and depression that a person is experiencing. Higher scores reflect a stronger impact. | ClinicalTrials.gov |
| Secondary | Composite Autonomic Symptom Score 31 | 2023-2027 | Is a questionnaire of 31 questions that assesses the autonomic nervous system symptoms. Higher score indicates greater autonomic symptom severity. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)