- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03627078
Motor Interference Therapy For Traumatic Memories (TIMCO)
July 27, 2020 updated by: Edgar Daniel Crail Melendez, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
The Effect of Motor Interference Therapy In Traumatic Memories: A Controlled Clinical Trial
The aim of the study is to compare the effect of motor interference therapy (TIM) to reduce the intensity of discomfort (distress) generated by a traumatic memory compared to a relaxation control maneuver, immediately after the intervention, a week, a month and six months after intervention.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The investigators treated 10 patients with autobiographical traumatic memories using finger tapping tasks, (Motor Interference Therapy <TIM>)in a pilot study with amazing results and a solid size effect.
The investigators decided to challenge the intervention using a control task (Jacobson´s progressive relaxation exercises) The hypothesis consists in achieving a 30% reduction of the distress, (measured with Visual Analogue Scale) by using TIM compared with the control task.
Patients with traumatic memories will be enrolled in to one of two treatment modalities.
The first group will receIve motor interference therapy and the second group will receive a control task (relaxation exercises).
Both groups will be assessed using the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS) immediately after, a week after, a month after and six months after the treatment for follow up.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ciudad De Mexico
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Mexico, Ciudad De Mexico, Mexico, 14269
- Instituto Nacional de Neurologia Y Neurocirugia Mvs
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-
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.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients older than 16 years
- Spanish as a native language
- Give written informed consent
- having at least 1 traumatic memory causing distress
Exclusion Criteria:
- Neurological or psychiatric disorders that affect the capacity of verbal comprehension and judgment, such as dementia, psychosis, mental retardation or other cognitive alteration that does not allow them to perform the tasks indicated in the TIM or SHAM
- History of recent substance abuse
- Patients with significant hearing loss or some other hearing impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motor Interference Therapy
Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS).
After that, patients will listen to an audio track twice and follow the instructions.
The first four minutes of the audio track instruct the subjects to tap their fingers in response to specific sounds.
During the remaining ten minutes, the patients will be asked to recall a traumatic memory while simultaneously are tapping their fingers.
Patients must complete at least 80% of the motor task in order to be included.
We will reassess a week, a month and six months after the intervention, using all three scales.
|
Other Names:
|
Sham Comparator: Relaxation Exercise
Initial interview applying the Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R), the visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D), and a simple visual-analogue scale (VAS).
After that, patients will listen to an audio track twice and follow the instructions.
The first four minutes of the audio track instruct the subjects in how to do the exercises.
During the remaining 10 minutes will hear commands for performing progressive muscle tension-relaxation exercises while the patient evoked the traumatic memory.
Patients must complete at least 80% of the motor task in order to be included.
We will reassess a week, a month and six months after the intervention, using all three scales.
|
In a top-down sequence, beginning with the upper body and proceeding to the lower parts.
patients contract and relax a specific muscle group following the instructions given by the audio track.
We use a shorter version that excludes the legs because of the time.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Visual Analogue Scale (EVA)
Time Frame: baseline, immediately, 1 week, 1 month, 6 months
|
measures the distress related to traumatic memories in 1-10
|
baseline, immediately, 1 week, 1 month, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spanish version of the PTSD Symptom Severity Scale-Revised (EGS-R)
Time Frame: baseline, 1 week, 1 month, 6 months
|
Posttraumatic stress disorder scale
|
baseline, 1 week, 1 month, 6 months
|
visual analogue scale (EQ-VAS) from EuroQol 5D (EQ-5D)
Time Frame: baseline, 1 week, 1 month, 6 months
|
as a gauge of health-related quality of lif
|
baseline, 1 week, 1 month, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Edgar D Crail-Melendez, MD, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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 Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
March 30, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 8, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 13, 2018
Study Record Updates
Last Update Posted (Actual)
July 29, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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