NCT01864707

Brief Summary

The main aim of this trial is to evaluate whether additional acupuncture or mindfulness-based stress reduction is more efficacious than usual care only to reduce fatigue in patients with multiple sclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable

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

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2.2 years

First QC Date

April 2, 2013

Last Update Submit

January 27, 2016

Conditions

FatigueMultiple Sclerosis

Keywords

multiple sclerosis, fatigue

Outcome Measures

Primary Outcomes (1)

  • fatigue severity scale

    12 weeks

Secondary Outcomes (14)

  • fatigue severity scale

    26 weeks

  • modified fatigue impact scale

    baseline, 8 weeks, 26 weeks

  • therapy response rates

    12 weeks

  • expanded disability status scale

    baseline, 12 weeks, 26 weeks

  • multipe sclerosis functional composite scale

    baseline, 12 weeks, 26 weeks

  • +9 more secondary outcomes

Other Outcomes (3)

  • fMRI

    baseline, 12 weeks, 26 weeks

  • Dynamics of saccade parameters

    baseline, 12 weeks, 26 weeks, and directly after one acupuncture session

  • Qualitative interviews regarding therapy

    26 weeks

Study Arms (3)

usual care + acupuncture

EXPERIMENTAL

standardized acupuncture treatment in addition to usual care

Other: Usual care + acupuncture

usual care+mbsr

EXPERIMENTAL

mindfulness based stress reduction in addition to usual care not recruiting anymore

Other: usual care+mbsr

usual care

ACTIVE COMPARATOR

usual care without additional treatment

Other: usual care

Interventions

Usual care + acupunctureOTHER

Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care

usual care + acupuncture
usual care+mbsrOTHER

Patients of this group receive mindfulness based stress reduction in addition to usual care

usual care+mbsr
usual careOTHER

Patients in this group will follow the same treatment for fatigue they received at study entry

usual care

Eligibility Criteria

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

You may qualify if:

  • female or male
  • to 65 years of age
  • able to give oral and signed written informed consent
  • clinical diagnosis of multiple sclerosis
  • fatigue in "multiple sclerosis" for at least 3 months
  • patient's mental and physical ability to participate in the trial
  • willingness to be randomised, to attend visits, to complete questionnaires, and willingness to participate and fMRI measurements

You may not qualify if:

  • fatigue because of a malignant disease
  • EDSS (Extended disability status scale) \> 6
  • fatigue specific acupuncture in the last 12 months
  • during the last 12 months performing of MBSR exercises learnt in the past
  • other new therapies are planned which could have a positive effect on fatigue (e.g. exercise, acupuncture, relaxation therapy)
  • for female patients: pregnancy or anticipated pregnancy during the intervention period
  • severe acute and or chronic disease which does not allow participation in the therapy
  • other limitations which do not allow participation in the therapy
  • alcohol or substance abuse
  • parallel participation in another clinical trial
  • BDI \> 29
  • contra indications for fMRI session (e.g. metal clips)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

FatigueMultiple Sclerosis

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Claudia M Witt, MD

    Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

  • Friedemann Paul, MD

    The NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 2, 2013

First Posted

May 30, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

January 29, 2016

Record last verified: 2016-01

Locations

DE(1)