Acupuncture for Headache Post-Traumatic Brain Injury: A Feasibility Study

University of Washington

Status: Terminated

Conditions: Traumatic Brain Injury; Post-Traumatic Headache

Treatments: Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04216173

STUDY00008281

KL2TR002317-03S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study evaluates and addresses challenges to implementing an acupuncture intervention for adults who have headaches after sustaining a moderate traumatic brain injury. Eligible participants will be recruited from Seattle and the surrounding areas to receive weekly acupuncture for 12 consecutive weeks. Participants will complete questionnaires to assess headache impact, depression, health-related quality of life, and cognitive function at the beginning of the study and every two weeks for the duration of the study. Participants will participate in structured interviews after the study for their views on the acceptability and tolerability of the study protocol.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Has a history of moderate traumatic brain injury (TBI) one to five years previously
• Currently under medical supervision for post-traumatic headache
• Have a score ≥ 3 on the Patient Health Questionnaire 2
• Have a raw summed score ≤ 6 on the PROMIS Cognitive Function Short Form v2.0 - Abilities 2a (part of PROMIS-29+2 Profile)
• Community-dwelling
• 18 years of age and older
• English Speaking
• Able to provide voluntarily consent

Exclusion Criteria

• History of multiple TBIs
• History of receiving acupuncture treatment in the past six months for the primary condition of headache
• An established diagnosis of PTSD
• Psychosis or agitation
• Other neurodegenerative disorders
• Other medical/surgical condition that precludes travel to participate in the intervention over the study duration
• Has an active skin lesion or acute trauma over or around the proposed acupuncture points
• History of trauma to the head that currently prevents the use of acupuncture points along the midline of the scalp
• Persons who are pregnant
• Unable to provide informed consent for the research as identified as answering more than two incorrect responses on the Six-item Screener

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Acupuncture

Experimental group

Treatment:

Other: Acupuncture